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A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03665285
Enrollment
109
Registered
2018-09-11
Start date
2018-10-01
Completion date
2023-04-11
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Solid Tumors, Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma, Endometrial Cancer, Melanoma, CRC, Urothelial Carcinoma, Cholangiocarcinoma

Keywords

Advanced Cancer, Metastatic Cancer, NC318, Immunotherapy, PD-L1, Dose Escalation, Biomarker, PK, Cohort Expansion, Solid Tumor

Brief summary

This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors.

Interventions

DRUGNC318

NC318 is an experimental antibody drug that may make the immune response more active against cancer.

Sponsors

NextCure, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC318 at the RP2D utilizing a Simon 2-stage design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and women aged 18 or older. * Willingness to provide written informed consent for the study. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Subjects with advanced unresectable and/or metastatic solid tumors. * Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. Note: There is no limit to the number of prior treatment regimens. * Presence of measurable disease based on RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion. * Able to provide pretreatment tumor tissue sample at Screening. * Subjects of childbearing potential (defined as female subjects who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea not caused by reversible conditions, diseases, or medications) and non-sterilized male subjects must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug.

Exclusion criteria

* Inability to comprehend or unwilling to sign the Informed Consent Form. * Screening laboratory values of: 1. Absolute neutrophil count \< 1.5 × 10\^9/L 2. Platelets \< 100 × 10\^9/L 3. Hemoglobin \< 9 g/dL or \< 5.6 mmol/L 4. Serum creatinine \> 1.5 × institutional upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 × ULN 6. Total bilirubin \> 1.5 × ULN. 7. International normalized ratio (INR) or prothrombin time (PT) \> 1.5 × ULN or activated partial thromboplastin time (aPTT) \> 1.5 × ULN * Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 7 days before the first administration of study drug. * Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug: 1. ≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy. Subjects must also not require chronic use of corticosteroids and must not have had radiation pneumonitis because of a treatment. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with medical monitor approval. Note: Bisphosphonates and denosumab are permitted medications. 2. ≤ 28 days for prior immunotherapy or persistence of active cellular therapy (e.g., chimeric antigen receptor T cell therapy; other cellular therapies must be discussed with the medical monitor to determine eligibility). 3. ≤ 28 days for a prior monoclonal antibody used for anticancer therapy except for denosumab. 4. ≤ 7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical steroids or corticosteroid use for radiographic procedures is permitted. Note: The use of corticosteroids equivalent to prednisone \</= 10mg/day is allowed. 5. ≤ 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational study drugs or devices. 6. ≤ 14 days for COVID-19 vaccine. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. * Receipt of a live vaccine within 30 days of planned start of study therapy. * Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). * Known active CNS metastases and/or carcinomatous meningitis. * Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry after treatment with curative intent. * Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease. * Documented known activating or driver mutations (i.e. EGFR mutations/amplification, BRAF mutations, ALK alterations, etc.) which have not been previously treated with a standard of care targeted therapy. * Subjects with screening QTc interval \>470 milliseconds are excluded. * Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti-infection treatment. * Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured. * Known history of HIV (HIV 1 or HIV 2 antibodies). * Known allergy or reaction to any component of study drug or formulation components. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study treatment. * Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0From enrollment through up to 90 days after end of treatment, an average of 1 yearThe number of participants who have had at least one TEAE during the study.

Secondary

MeasureTime frameDescription
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Approximately 1 yearTo assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Approximately 1 yearTo assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Approximately 1 yearTo evaluate progression-free survival (PFS), defined as the time from the first dose of NC318 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Approximately 1 yearTo assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Maximum Plasma Concentration (Cmax) of NC318Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.To evaluate the Maximum Plasma Concentration (Cmax) of NC318
Area Under the Curve (AUC) of NC318Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.To evaluate the Area Under the Curve (AUC) of NC318
Half-life (t1/2) of NC318Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.To evaluate the half-life (t1/2) of NC318
Overall Survival (OS)Approximately 1 yearTo evaluate overall survival (OS), defined as the time from the first dose of NC318 to death due to any cause.

Countries

United States

Participant flow

Recruitment details

109 participants took part in the study at 6 investigative sites in the United States from 01 October 2018 to 11 April 2023.

Pre-assignment details

The dose-escalation consisted of 7 planned cohorts (NC318 IV doses of 8 mg to 1600 mg). Phase 1b was a safety expansion of 3 cohorts (80 mg, 240 mg, and 400 mg). 49 participants were enrolled in Phase 1. A RP2D of 400 mg Q2W was initially evaluated in Phase 2 (N=47); an alternative RP2D of 800 mg weekly for 8 cycles, followed by 800 mg Q2W thereafter (N=13) was also evaluated.

Participants by arm

ArmCount
NC318 8mg
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
4
NC318 24mg
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
4
NC318 80mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
10
NC318 240mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
12
NC318 400mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
11
NC318 800mg
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
4
NC318 1600mg
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
4
Dose Expansion: 400mg Q2W
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
47
Dose Expansion: 800mg QW
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
13
Total109

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008
Overall StudyDisease Progression003100071
Overall StudyHospice000000020
Overall StudyPhysician Decision000000020
Overall StudyStarted New Anticancer Treatment1124112151
Overall StudyWithdrawal by Subject000010020

Baseline characteristics

CharacteristicTotalNC318 24mgNC318 80mgNC318 240mgNC318 400mgNC318 8mgNC318 800mgNC318 1600mgDose Expansion: 400mg Q2WDose Expansion: 800mg QW
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
51 Participants2 Participants6 Participants5 Participants3 Participants1 Participants1 Participants1 Participants24 Participants8 Participants
Age, Categorical
Between 18 and 65 years
58 Participants2 Participants4 Participants7 Participants8 Participants3 Participants3 Participants3 Participants23 Participants5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants0 Participants1 Participants3 Participants3 Participants1 Participants0 Participants0 Participants5 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
92 Participants4 Participants9 Participants9 Participants8 Participants3 Participants4 Participants4 Participants41 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
8 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants6 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants0 Participants0 Participants2 Participants2 Participants0 Participants0 Participants0 Participants5 Participants3 Participants
Race (NIH/OMB)
White
86 Participants4 Participants10 Participants9 Participants9 Participants4 Participants4 Participants4 Participants35 Participants7 Participants
Region of Enrollment
United States
109 participants4 participants10 participants12 participants11 participants4 participants4 participants4 participants47 participants13 participants
Sex: Female, Male
Female
65 Participants2 Participants6 Participants7 Participants6 Participants2 Participants3 Participants2 Participants30 Participants7 Participants
Sex: Female, Male
Male
44 Participants2 Participants4 Participants5 Participants5 Participants2 Participants1 Participants2 Participants17 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 42 / 40 / 104 / 123 / 111 / 41 / 47 / 476 / 13
other
Total, other adverse events
4 / 44 / 410 / 1012 / 1210 / 114 / 44 / 442 / 4712 / 13
serious
Total, serious adverse events
2 / 43 / 44 / 108 / 124 / 111 / 43 / 416 / 475 / 13

Outcome results

Primary

Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0

The number of participants who have had at least one TEAE during the study.

Time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year

Population: The Safety Analysis Set (SAS) will include all the subjects who receive any amount of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NC318 8mgNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.04 Participants
NC318 24mgNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.04 Participants
NC318 80mgNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.010 Participants
NC318 240mgNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.012 Participants
NC318 400mgNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.011 Participants
NC318 800mgNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.04 Participants
NC318 1600mgNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.04 Participants
Dose Expansion: 400mg Q2WNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.045 Participants
Dose Expansion: 800mg QWNumber of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.012 Participants
Secondary

Area Under the Curve (AUC) of NC318

To evaluate the Area Under the Curve (AUC) of NC318

Time frame: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.

Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. PK analysis only took place during the dose escalation portion of the study.

ArmMeasureValue (MEAN)Dispersion
NC318 8mgArea Under the Curve (AUC) of NC318171933 h*ng/mL—
NC318 24mgArea Under the Curve (AUC) of NC318112327 h*ng/mL—
NC318 80mgArea Under the Curve (AUC) of NC318290486 h*ng/mLStandard Deviation 115984
NC318 240mgArea Under the Curve (AUC) of NC318724225 h*ng/mLStandard Deviation 538755
NC318 400mgArea Under the Curve (AUC) of NC3181324013 h*ng/mLStandard Deviation 688403
NC318 800mgArea Under the Curve (AUC) of NC3184335767 h*ng/mLStandard Deviation 2288217
NC318 1600mgArea Under the Curve (AUC) of NC3189837043 h*ng/mLStandard Deviation 5163985
Secondary

Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NC318 8mgDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.13 Participants
NC318 24mgDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.10 Participants
NC318 80mgDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.18 Participants
NC318 240mgDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.12 Participants
NC318 400mgDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.15 Participants
NC318 800mgDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.13 Participants
NC318 1600mgDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.12 Participants
Dose Expansion: 400mg Q2WDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.114 Participants
Dose Expansion: 800mg QWDisease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.11 Participants
Secondary

Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Time frame: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.

ArmMeasureValue (MEDIAN)
NC318 8mgDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
NC318 24mgDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
NC318 80mgDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
NC318 240mgDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
NC318 400mgDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
NC318 800mgDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
NC318 1600mgDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
Dose Expansion: 400mg Q2WDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.18.11 months
Dose Expansion: 800mg QWDuration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
Secondary

Half-life (t1/2) of NC318

To evaluate the half-life (t1/2) of NC318

Time frame: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.

Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. PK analysis only took place during the dose escalation portion of the study.

ArmMeasureValue (MEAN)Dispersion
NC318 8mgHalf-life (t1/2) of NC31846.16 hours—
NC318 24mgHalf-life (t1/2) of NC31824.62 hours—
NC318 80mgHalf-life (t1/2) of NC31846.41 hoursStandard Deviation 10.68
NC318 240mgHalf-life (t1/2) of NC31834.81 hoursStandard Deviation 13.15
NC318 400mgHalf-life (t1/2) of NC31832.25 hoursStandard Deviation 10.37
NC318 800mgHalf-life (t1/2) of NC31832.67 hoursStandard Deviation 6.57
NC318 1600mgHalf-life (t1/2) of NC31832.71 hoursStandard Deviation 6
Secondary

Maximum Plasma Concentration (Cmax) of NC318

To evaluate the Maximum Plasma Concentration (Cmax) of NC318

Time frame: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.

Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. PK analysis only took place during the dose escalation portion of the study.

ArmMeasureValue (MEAN)Dispersion
NC318 8mgMaximum Plasma Concentration (Cmax) of NC3183010 ng/mLStandard Deviation 2194
NC318 24mgMaximum Plasma Concentration (Cmax) of NC3185020 ng/mLStandard Deviation 774
NC318 80mgMaximum Plasma Concentration (Cmax) of NC31817130 ng/mLStandard Deviation 5120
NC318 240mgMaximum Plasma Concentration (Cmax) of NC31855025 ng/mLStandard Deviation 12393
NC318 400mgMaximum Plasma Concentration (Cmax) of NC31897816 ng/mLStandard Deviation 19174
NC318 800mgMaximum Plasma Concentration (Cmax) of NC318352500 ng/mLStandard Deviation 310095
NC318 1600mgMaximum Plasma Concentration (Cmax) of NC318329750 ng/mLStandard Deviation 99399
Secondary

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NC318 8mgObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.11 Participants
NC318 24mgObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.10 Participants
NC318 80mgObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.10 Participants
NC318 240mgObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.10 Participants
NC318 400mgObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.11 Participants
NC318 800mgObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.10 Participants
NC318 1600mgObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.10 Participants
Dose Expansion: 400mg Q2WObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.12 Participants
Dose Expansion: 800mg QWObjective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.10 Participants
Secondary

Overall Survival (OS)

To evaluate overall survival (OS), defined as the time from the first dose of NC318 to death due to any cause.

Time frame: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.

ArmMeasureValue (MEDIAN)
NC318 8mgOverall Survival (OS)NA months
NC318 24mgOverall Survival (OS)NA months
NC318 80mgOverall Survival (OS)NA months
NC318 240mgOverall Survival (OS)11.04 months
NC318 400mgOverall Survival (OS)6.18 months
NC318 800mgOverall Survival (OS)NA months
NC318 1600mgOverall Survival (OS)NA months
Dose Expansion: 400mg Q2WOverall Survival (OS)NA months
Dose Expansion: 800mg QWOverall Survival (OS)3.55 months
Secondary

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To evaluate progression-free survival (PFS), defined as the time from the first dose of NC318 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame: Approximately 1 year

Population: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.

ArmMeasureValue (MEDIAN)
NC318 8mgProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1NA months
NC318 24mgProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.11.32 months
NC318 80mgProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.15.72 months
NC318 240mgProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.11.86 months
NC318 400mgProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.12.54 months
NC318 800mgProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.13.93 months
NC318 1600mgProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.13.29 months
Dose Expansion: 400mg Q2WProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.12.04 months
Dose Expansion: 800mg QWProgression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.11.79 months

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026