Pancreatic Adenocarcinoma
Conditions
Keywords
glycogen biosynthesis, Glycogen synthase kinase-3 (GSK-3), NF-κB pathway
Brief summary
This trial examines how Pancreatic Adenocarcinoma reacts to the addition of 9-ING-41 and retifanlimab to the standard of care chemotherapy treatment, to see if using this combination will help and is able to effect disease progression.
Detailed description
Given the role of GSK-3β in immune regulation, the combination of GSK-3β inhibition with PD 1 inhibition may be expected to provide synergistic anti-tumor efficacy. The excellent safety profile of 9-ING-41, along with preclinical and clinical evidence of anti-tumor activity in pancreatic cancer, provides a strong rationale to evaluate the efficacy of 9-ING-41 in combination with a PD 1 inhibitor plus standard chemotherapy (gemcitabine/nab-paclitaxel) as frontline therapy for patients with advanced PDAC. The combination of 9-ING-41 and retifanlimab with gemcitabine/nab-paclitaxel has not previously been administered to human subjects. In the 1801 study, 9-ING- 41 has been administered in combination with various chemotherapy regimens including gemcitabine/nab-paclitaxel, with one 9-ING-41-related SAE (transient visual change) documented to date. Retifanlimab alone has been well-tolerated when administered for up to 2 years in patients with anal cancer. Overall, based on previous nonclinical and clinical experience, both of these agents appear to have an acceptable safety profile and do not appear to have significant overlapping toxicities. However, it is possible that when they are administered together and in combination with gemcitabine/nab-paclitaxel, more frequent or severe AEs, or new AEs not previously observed with any of these agents administered alone, may occur. It is not known if administration of 9-ING-41 and retifanlimab will act synergistically to provide increased anti-tumor activity compared to gemcitabine/nab-paclitaxel alone. Subjects in this study should not expect to benefit directly by their participation in the study. The data collected in this study may benefit future cancer patients.
Interventions
DRUG9-ING-41
9-ING-41 is a small molecule potent selective GSK-3β inhibitor
DRUGRetifanlimab
Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
DRUGGemcitabine
cytotoxic chemotherapy agent
DRUGAbraxane
cytotoxic chemotherapy agent
Sponsors
Actuate Therapeutics Inc.
Incyte Corporation
Anwaar Saeed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntarily written informed consent and willingness/ability to comply with the protocol requirements * Has pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer AND is previously untreated with systemic agents in the advanced/metastatic setting. * Must have at least 1 measurable lesion per RECIST v1.1. Lesions that are radiated should not count as target lesions unless there is evidence of growth post radiation on a subsequent scan prior to trial enrollment. * Must have available archived tumor tissue at study entry (metastatic tissue preferred to primary tissue) * Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1000/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100,000/mL. * Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 2.5 x ULN (≤ 5 X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells); bilirubin ≤ 1.5 x ULN. * Adequate renal function: creatinine clearance CrCl \> 60 mL/min measured or calculated by Cockcroft- Gault (C-G) equation (estimated glomerular filtration rate \[eGFR\] can also be used in place of CrCl). * Serum amylase and lipase ≤ 1.5 x ULN * Eastern Co-operative Oncology Group (ECOG) performance status (PS) 0 - 1 * Has received the final dose of any of the following treatments/ procedures within the specified minimum intervals before first dose of study drug: Focal radiation therapy - 7 days Surgery with general anesthesia - 7 days Surgery with local anesthesia - 7 days
Exclusion criteria
* Is pregnant or lactating. * Is known to be hypersensitive to any of the components or metabolites of 9-ING-41 or to the excipients used in its formulation, or known sensitivity to one of the chemotherapeutic agents or to the PD-1 inhibitor. * History of receiving prior treatment with any anti-PD-1, PD-L1 or PD-L2 agent. * Has endocrine or acinar pancreatic carcinoma. * Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia, anemia not requiring transfusion support and infertility. Recovery is defined as ≤ Grade 1 or baseline severity per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0). * Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of 9-ING-41, or cardiac arrhythmia requiring medical treatment detected at screening. * Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41 or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator or study medical coordinator. * Has symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI). Patients with stable brain metastases or leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug. * Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered). * Has any medical and/or social condition that, in the opinion of the investigator would preclude study participation. * Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial. * Has a current malignancy other than pancreatic cancer. * Known immunodeficiency syndrome or active autoimmune disease or requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg/day of prednisone or equivalent). * Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. * Palliative radiation therapy administered within 1 week of first dose of study treatment or radiation therapy that is \> 30 Gy within 6 months of the first dose of study treatment. * Has received systemic antibiotics ≤ 7 days prior to the first dose of study drug. * History of organ transplant, including allogeneic stem cell transplantation. * Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids). * Known allergy or hypersensitivity to any component of retifanlimab or formulation components. * Has received a live vaccine within 28 days of the planned start of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Up to approximately 11 months from baseline | Percentage of patients with stable disease (SD), Complete Response (CR), or Partial Response (PR) for ≥16 weeks during treatment. Per RECIST v1.1, (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 12 months (from enrollment) | Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Adverse Events and Serious Adverse Events | Up to 12 months (from enrollment) | Number of participants with overall treatment-related adverse events (AE) and/or serious adverse events (SAE) at least possibly related as assessed by CTCAE v5.0. |
| Best Response | Up to 12 months (from enrollment) | Number of patients with Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Progression-free Survival (PFS) | Up to 12 months (from enrollment) | Time from study enrollment until objective tumor progression or death. Per RECISIT v1.1, Progressive Disease (PD) is ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Overall Survival (OS) | Up to 24 months | Time patients are alive from study enrollment to death from any cause. |
| Duration of Response (DOR) | Up to 12 months (from enrollment) | Time from documentation of tumor response to disease progression. Per RECISIT v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane * intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane |
|---|---|
| Age, Continuous | 57.14286 years STANDARD_DEVIATION 5.607939 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 7 |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 4 / 7 |
Outcome results
Primary
Disease Control Rate (DCR)
Percentage of patients with stable disease (SD), Complete Response (CR), or Partial Response (PR) for ≥16 weeks during treatment. Per RECIST v1.1, (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to approximately 11 months from baseline
Population: Treated patients who were radiologically evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Disease Control Rate (DCR) | 100 percentage of patients |
Secondary
Adverse Events and Serious Adverse Events
Number of participants with overall treatment-related adverse events (AE) and/or serious adverse events (SAE) at least possibly related as assessed by CTCAE v5.0.
Time frame: Up to 12 months (from enrollment)
Population: All patients who receive at least one dose of 9-ING-41
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Nail discoloration | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Aspartate aminotransferase increased | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Alanine aminotransferase increased | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Alopecia | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Anemia | 5 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Anorexia | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Ataxia | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Blurred vision | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Colitis | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Constipation | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Diarrhea | 5 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Dizziness | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Edema limbs | 3 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Eye disorder | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Fatigue | 4 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Febrile neutropenia | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Fever | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Flu like symptoms | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Headache | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Hyperkalemia | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Hypokalemia | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Hypomagnesemia | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Hyponatremia | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Mucositis oral | 3 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Nail changes | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Nausea | 4 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Neutrophil count decreased | 4 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Papulopustular rash | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Periorbital Dermatitis | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Peripheral motor neuropathy | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Peripheral sensory neuropathy | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Platelet count decreased | 3 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Pruritus | 3 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Rash maculo-papular | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Sepsis | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Skin and subcutaneous tissue disorders - Other, specify | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Syncope | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Throat pain | 1 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Vomiting | 2 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | Weight loss | 4 participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Adverse Events and Serious Adverse Events | White blood cell decreased | 2 participants |
Secondary
Best Response
Number of patients with Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 months (from enrollment)
Population: Treated patients who were radiologically evaluable.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Best Response | Complete Response | 0 Participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Best Response | Partial Response | 2 Participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Best Response | Stable Disease | 4 Participants |
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Best Response | Progressive Disease | 0 Participants |
Secondary
Duration of Response (DOR)
Time from documentation of tumor response to disease progression. Per RECISIT v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 months (from enrollment)
Population: Treated patients who were radiologically evaluable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Duration of Response (DOR) | 5.273 months |
Secondary
Overall Response Rate (ORR)
Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to 12 months (from enrollment)
Population: Treated patients who were radiologically evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Overall Response Rate (ORR) | 33 percentage of patients |
Secondary
Overall Survival (OS)
Time patients are alive from study enrollment to death from any cause.
Time frame: Up to 24 months
Population: All study enrolled participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Overall Survival (OS) | 10.72596 months |
Secondary
Progression-free Survival (PFS)
Time from study enrollment until objective tumor progression or death. Per RECISIT v1.1, Progressive Disease (PD) is ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame: Up to 12 months (from enrollment)
Population: Treated patients evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 9-ING-41 Plus Retifanlimab Plus Gem/Abraxane | Progression-free Survival (PFS) | 6.785481 months |