Description:
This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase
1 Dose Escalation phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in
combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma
followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid
Tumors
Title
- Brief Title: GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma
- Official Title: A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination With an Anti-PD-1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 With Standard of Care or in Combination With an Anti-PD-1 Antibody in Patients With Specified Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
GB1275-1101 (KEYNOTE-A36)
- NCT ID:
NCT04060342
Conditions
- Pancreatic Adenocarcinoma
- Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma
- Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
- Triple Negative Breast Cancer
- Castration-resistant Prostate Cancer
- Microsatellite Stable Colorectal Cancer
- Non-small Cell Lung Cancer
- Small-cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Urothelial Carcinoma
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
Interventions
| Drug | Synonyms | Arms |
|---|
| GB1275 | Investigational | Phase 1: Regimen A - GB1275 monotherapy |
| nab-paclitaxel and gemcitabine | Abraxane and Gemzar | Phase 1: Regimen C - GB1275 with Standard of Care (SOC) |
| pembrolizumab | Anti-PD-1 | Phase 1: Regimen B - GB1275 with an Anti-PD-1 |
Purpose
This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase
1 Dose Escalation phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in
combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma
followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid
Tumors
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Phase 1: Regimen A - GB1275 monotherapy | Experimental | GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID). | |
| Phase 1: Regimen B - GB1275 with an Anti-PD-1 | Experimental | GB1275 with pembrolizumab dose escalation and expansion:
GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W). | |
| Phase 1: Regimen C - GB1275 with Standard of Care (SOC) | Experimental | GB1275 with SOC dose escalation:
GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI) | - GB1275
- nab-paclitaxel and gemcitabine
|
| Phase 2: Cohort 1 - GB1275 with SOC | Experimental | GB1275 with SOC Basket Cohort in patients with newly diagnosed metastatic pancreatic cancer:
GB1275 oral administration; twice per day (BID) and nab-paclitaxel and gemcitabine per USPI. | - GB1275
- nab-paclitaxel and gemcitabine
|
| Phase 2: Cohort 2 - GB1275 with an Anti-PD-1 | Experimental | GB1275 with pembrolizumab Basket Cohort in patients with MSS colorectal cancer:
GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W). | |
| Phase 2: Cohort 3 - GB1275 with an Anti-PD-1 | Experimental | GB1275 with pembrolizumab Basket Cohort in patients with gastric/GEJ cancer, PD-L1 positive:
GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W). | |
Eligibility Criteria
Inclusion Criteria:
- Subject has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group
(ECOG) Performance Scale.
- Women of childbearing potential must use an acceptable method of contraception
Phase 1
Subjects with the the following:
- Regimen A and B:
- pancreatic adenocarcinoma,
- esophageal adenocarcinoma, or esophageal squamous cell carcinoma, or
- gastric/gastroesophageal junction adenocarcinoma, or
- TNBC, or
- prostate cancer, or
- colorectal adenocarcinoma, or subjects with tumor types that have progressed
after receiving initial treatment benefit rom the last single agent checkpoint
inhibitor that is approved for the indication or in combination with standard of
care therapy, for example, non-small cell lung cancer, small cell lung cancer,
head and neck squamous cell carcinoma, urothelial carcinoma, renal cell
carcinoma, and hepatocellular carcinoma, etc.
- Regimen C: newly diagnosed stage IV pancreatic cancer
Phase 2
- Cohort 1: pancreatic cancer.
- Cohort 2: colorectal cancer
- Cohort 3: gastric/GEJ adenocarcinoma
Exclusion Criteria:
- History of another malignancy within 2 years prior to first study drug(s)
administration, unless the malignancy was treated with curative intent and the
likelihood of relapse is <5% in 2 years
- Pregnant or nursing
- Known history of testing positive for human immunodeficiency virus (HIV)
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Positive test for Hepatitis B virus surface antigen (HBsAg) or a and/or positive Hep C
antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA)
indicating acute or chronic infection.
Other protocol-defined inclusion/exclusion criteria will apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Phase 1 - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs) |
| Time Frame: | Regimen A and B dose escalation Days 1-21, Regimen C dose escalations Days 1-36 days |
| Safety Issue: | |
| Description: | Maximum observed plasma concentration |
Secondary Outcome Measures
| Measure: | Phase 1 - Regimen C: Cmax of GB1275 |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Maximum observed plasma concentration |
| Measure: | Phase 1 - Regimen C: Ctrough of GB1275 |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Trough observed plasma concentration |
| Measure: | Phase 1 - Regimen C: Tmax of GB1275 |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Time of maximum observed plasma concentration |
| Measure: | Phase 1 - Regimen C: t1/2 of GB1275 |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Terminal phase elimination half-life |
| Measure: | Phase 1 - Regimen C: AUC of GB1275 |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Area under the plasma concentration-time curve |
| Measure: | Phase 1 - Regimen C: CL/F of GB1275 |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Oral clearance |
| Measure: | Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Maximum observed plasma concentration |
| Measure: | Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine) |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Time of maximum observed plasma concentration |
| Measure: | Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine |
| Time Frame: | From baseline through 30 days last dose |
| Safety Issue: | |
| Description: | Area under the plasma concentration-time curve |
| Measure: | Phase 2 - Basket Cohorts 1, 2, and 3: Duration of Response (DOR) |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | DOR defined as time from date of objective response to first documented date of disease progression or death |
| Measure: | Phase 2 - Basket Cohorts 1, 2, and 3: Time to Response (TTR) |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | TTR defined as time from first dose to first date of objective response |
| Measure: | Phase 2 - Basket Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR) |
| Time Frame: | 6 months |
| Safety Issue: | |
| Description: | CBR defined as proportion of subjects with confirmed CR, PR, or stable disease (SD) at six months. |
| Measure: | Phase 2 - Basket Cohorts 1, 2, and 3: Progression Free Survival (PFS) |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | PFS defined as time from first dose to first documented date of disease progression or death. |
| Measure: | Phase 2 - Basket Cohorts 1, 2, and 3: Time to Progression (TTP) |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | TTP defined as time from first dose to first documented date of disease progression. |
| Measure: | Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS) |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | OS defined as time from first dose to date of death. |
| Measure: | Phase 2 - Basket Cohorts 1, 2, and 3: Incidence of AEs |
| Time Frame: | Basket Cohorts 1, 2 and 3 from baseline through 30 days last dose. |
| Safety Issue: | |
| Description: | |
| Measure: | Phase 2 - Basket Cohort 1, 2 and 3: PK profile of GB1275 |
| Time Frame: | Basket Cohorts 1, 2, and 3 from baseline through 30 days last dose. |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. |
Trial Keywords
- GEJ adenocarcinoma
- TNBC
- MSS mCRC
- PD-L1 + gastric cancer
- PD-L1 positive gastric cancer
- NSCLC
- SCLC
- newly diagnosed stage IV pancreatic adenocarcinoma
- HCC
- RCC
- HNSCC
- Transitional Cell Carcinoma
Last Updated
October 19, 2020
