Advanced or Metastatic Solid Tumors, Breast Cancer, Non-small Cell Lung Cancer, Ovarian Cancer
Conditions
Keywords
Advanced Cancer, Metastatic Cancer, NC762, Solid Tumor, Immunotherapy, PK, Ovarian Cancer, Lung Cancer, Breast Cancer
Brief summary
This research study is studying a new drug, NC762, as a possible treatment for advanced or metastatic solid tumors.
Interventions
DRUGNC762
NC762 is an experimental antibody drug that may make the immune response more active against cancer
Sponsors
NextCure, Inc.
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 NC762 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. * ECOG performance status 0 to 1. * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * 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. * Phase 1a Dose Escalation (optional), Phase 1b Safety Expansion, and Phase 2 (mandatory): Willingness to undergo pretreatment and on-treatment tumor biopsies (core or excisional). * Female subjects of childbearing potential (defined as women who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea) and non-sterilized male subjects of childbearing potential 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. Females of child-bearing potential must have a negative serum pregnancy test at screening.
Exclusion criteria
* Inability to comprehend or unwilling to sign the ICF. * Laboratory and medical history parameters not within the protocol-defined range. 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) and measured or calculated creatinine clearance \< 50 mL/min for subjects with creatinine levels \> 1.5 × institutional ULN. 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN. With the following exceptions: subjects with documented liver metastases AST and/or ALT ≤ 5 × ULN. Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 ×ULN. 6. Total bilirubin ≥ 1.5 × ULN. 7. International normalized ratio (INR) or prothrombin time (PT) \> 1.5 × ULN; Activated partial thromboplastin time (aPTT) \> 1.5 × ULN, except for subjects on anticoagulation. * 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, hormonal therapy or radiation therapy. Subjects 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. 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 mAb used for anticancer therapy except for denosumab. 4. ≤ 7 days for immune-suppressive-based treatment for any reason. 5. ≤ 28 days or 5 half-lives, t½, (whichever is longer) before the first dose for all other investigational study drugs or devices. For investigational agents with long half-lives (e.g., \> 5 days), enrollment before the fifth t½ requires medical monitor approval. 6. ≤ 14 days for a COVID-19 vaccine. Note: For 2-dose vaccines, subjects must wait at least 14 days after administration of the 2nd dose of the vaccine prior to receiving the first dose of the study drug. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy and radiation therapy) 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 concurrent malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. * Evidence of active, noninfectious pneumonitis or history of 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 (corrected by Fridericia) 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | From enrollment through up to 90 days after end of treatment, an average of 1 year | Frequency, duration, and severity of treatment-emergent adverse events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Approximately 1 year | 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. |
| Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Approximately 1 year | 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. |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Approximately 1 year | To evaluate progression-free survival (PFS), defined as the time from the first dose of NC762 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) v1.1 | Approximately 1 year | 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 |
| Maximum Serum Concentration (Cmax) of NC762 | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. | To evaluate the Maximum Serum Concentration (Cmax) of NC762 |
| Area Under the Curve (AUC) of NC762 | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. | To evaluate the Area Under the Curve (AUC) of NC762 |
| Half-life (T1/2) of NC762 | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. | To evaluate the Half-life (T1/2) of NC762 |
| Overall Survival (OS) | Approximately 1 year | To evaluate overall survival (OS), defined as the time from the first dose of NC762 to death due to any cause. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.5mg/kg NC762 Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 4 |
| 1.5mg/kg NC762 Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 4 |
| 5mg/kg NC762 Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 3 |
| 10mg/kg NC762 Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 11 |
| 20mg/kg NC762 Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 18 |
| Total | 40 |
Baseline characteristics
| Characteristic | 0.5mg/kg NC762 | 1.5mg/kg NC762 | 5mg/kg NC762 | 10mg/kg NC762 | 20mg/kg NC762 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 4.03 | 74.0 years STANDARD_DEVIATION 8.76 | 74.3 years STANDARD_DEVIATION 3.21 | 61.5 years STANDARD_DEVIATION 13.13 | 57.0 years STANDARD_DEVIATION 13.55 | 60.4 years STANDARD_DEVIATION 13.62 |
| Body Mass Index (BMI) | 22.693 kg/m2 STANDARD_DEVIATION 4.6895 | 29.365 kg/m2 STANDARD_DEVIATION 4.2638 | 26.543 kg/m2 STANDARD_DEVIATION 4.5224 | 26.366 kg/m2 STANDARD_DEVIATION 5.5265 | 25.937 kg/m2 STANDARD_DEVIATION 6.0424 | 26.113 kg/m2 STANDARD_DEVIATION 5.496 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 3 Participants | 11 Participants | 17 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 2 Participants | 11 Participants | 14 Participants | 34 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 3 participants | 11 participants | 18 participants | 40 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 7 Participants | 18 Participants | 28 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 2 Participants | 4 Participants | 0 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 1 / 4 | 2 / 3 | 2 / 11 | 9 / 18 |
| other Total, other adverse events | 4 / 4 | 3 / 4 | 3 / 3 | 11 / 11 | 17 / 18 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 1 / 3 | 1 / 11 | 11 / 18 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Frequency, duration, and severity of treatment-emergent adverse events (AEs)
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5mg/kg NC762 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | 4 Participants |
| 1.5mg/kg NC762 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | 3 Participants |
| 5mg/kg NC762 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | 3 Participants |
| 10mg/kg NC762 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | 11 Participants |
| 20mg/kg NC762 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | 18 Participants |
Secondary
Area Under the Curve (AUC) of NC762
To evaluate the Area Under the Curve (AUC) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. AUC from time 0 to the last measurable concentration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 5 | 2040 h*ug/mL | Standard Deviation 976 |
| 0.5mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 1 | 1170 h*ug/mL | Standard Deviation 439 |
| 1.5mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 1 | 2130 h*ug/mL | Standard Deviation 481 |
| 1.5mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 5 | 5090 h*ug/mL | Standard Deviation 684 |
| 5mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 5 | NA h*ug/mL | — |
| 5mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 1 | 13600 h*ug/mL | Standard Deviation 2620 |
| 10mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 1 | 28300 h*ug/mL | Standard Deviation 8990 |
| 10mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 5 | 39100 h*ug/mL | Standard Deviation 38000 |
| 20mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 1 | 47300 h*ug/mL | Standard Deviation 13200 |
| 20mg/kg NC762 | Area Under the Curve (AUC) of NC762 | Cycle 5 | 74900 h*ug/mL | Standard Deviation 39100 |
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 FAS includes all subjects enrolled in the study who received at least one full dose of NC762
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5mg/kg NC762 | Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 2 Participants |
| 1.5mg/kg NC762 | Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 3 Participants |
| 5mg/kg NC762 | Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 2 Participants |
| 10mg/kg NC762 | Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 3 Participants |
| 20mg/kg NC762 | Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 6 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 NC762
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 0.5mg/kg NC762 | Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | NA months |
| 1.5mg/kg NC762 | Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | NA months |
| 5mg/kg NC762 | Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | NA months |
| 10mg/kg NC762 | Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | NA months |
| 20mg/kg NC762 | Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | NA months |
Secondary
Half-life (T1/2) of NC762
To evaluate the Half-life (T1/2) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. Half-Life Lambda z (h).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 1 | 114 h | Standard Deviation 23.8 |
| 1.5mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 1 | 131 h | Standard Deviation 29 |
| 5mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 5 | NA h | — |
| 5mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 1 | 129 h | Standard Deviation 12 |
| 10mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 5 | NA h | — |
| 10mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 1 | 124 h | Standard Deviation 24.5 |
| 20mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 5 | NA h | — |
| 20mg/kg NC762 | Half-life (T1/2) of NC762 | Cycle 1 | 129 h | Standard Deviation 20.5 |
Secondary
Maximum Serum Concentration (Cmax) of NC762
To evaluate the Maximum Serum Concentration (Cmax) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 1 | 11.2 ug/mL | Standard Deviation 2.62 |
| 0.5mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 5 | 14.6 ug/mL | Standard Deviation 6.08 |
| 1.5mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 1 | 18.5 ug/mL | Standard Deviation 4.98 |
| 1.5mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 5 | 35.8 ug/mL | Standard Deviation 6.21 |
| 5mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 1 | 119 ug/mL | Standard Deviation 0.707 |
| 5mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 5 | NA ug/mL | — |
| 10mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 5 | 289 ug/mL | Standard Deviation 197 |
| 10mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 1 | 227 ug/mL | Standard Deviation 69.6 |
| 20mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 1 | 440 ug/mL | Standard Deviation 102 |
| 20mg/kg NC762 | Maximum Serum Concentration (Cmax) of NC762 | Cycle 5 | 477 ug/mL | Standard Deviation 163 |
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 NC762
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5mg/kg NC762 | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| 1.5mg/kg NC762 | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| 5mg/kg NC762 | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| 10mg/kg NC762 | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
| 20mg/kg NC762 | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 Participants |
Secondary
Overall Survival (OS)
To evaluate overall survival (OS), defined as the time from the first dose of NC762 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 NC762
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 0.5mg/kg NC762 | Overall Survival (OS) | NA months |
| 1.5mg/kg NC762 | Overall Survival (OS) | 15.74 months |
| 5mg/kg NC762 | Overall Survival (OS) | 7.66 months |
| 10mg/kg NC762 | Overall Survival (OS) | NA months |
| 20mg/kg NC762 | Overall Survival (OS) | 7.92 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 NC762 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 FAS includes all subjects enrolled in the study who received at least one full dose of NC762
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 0.5mg/kg NC762 | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 12.07 weeks |
| 1.5mg/kg NC762 | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 13.00 weeks |
| 5mg/kg NC762 | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 33.29 weeks |
| 10mg/kg NC762 | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 7.43 weeks |
| 20mg/kg NC762 | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 7.57 weeks |