Clinical trial NCT04060342: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
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
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
Lead sponsor: Gossamer Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-08-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1 - Dose Escalation of 3 different Regimens and Expansion, Phase 2 - Basket Expansion of 3 Cohorts
Primary purpose: TREATMENT

Brief summary: This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation/Expansion 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

Detailed description: Note: The Phase 2 portion of the study was not initiated.

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

Primary outcomes:
measure: Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)
timeFrame: Regimen A and B dose escalation Days 1-21, Regimen C dose escalation Days 8-36 days
measure: Phase 1 Dose Escalation - Regimens A, B, and C and Phase 1 Expansion - Regimen B: Incidence of adverse events (AEs)
timeFrame: Regimen A and C from first dose through 30 days post last dose, Regimen B from first dose through 90 days post last dose
measure: Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Ctrough of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Tmax of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: t1/2 of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine)
timeFrame: From first dose through 30 days post last dose
measure: Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine
timeFrame: From first dose through 30 days post last dose
measure: Phase 2 - Basket Cohorts 1, 2, and 3: Duration of Response (DOR)
timeFrame: 24 months
measure: Phase 2 - Basket Cohorts 1, 2, and 3: Time to Response (TTR)
timeFrame: 24 months
measure: Phase 2 - Basket Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR)
timeFrame: 6 months
measure: Phase 2 - Basket Cohorts 1, 2, and 3: Progression Free Survival (PFS)
timeFrame: 24 months
measure: Phase 2 - Basket Cohorts 1, 2, and 3: Time to Progression (TTP)
timeFrame: 24 months
measure: Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS)
timeFrame: 24 months
measure: Phase 2 - Basket Cohorts 1, 2, and 3: Incidence of AEs
timeFrame: Basket Cohorts 1 from first dose through 30 days post last dose, Basket Cohorts 2 and 3 from first dose through 90 days post last dose.
measure: Phase 2 - Basket Cohort 1, 2 and 3: PK profile of GB1275
timeFrame: Basket Cohorts 1, 2, and 3 from first dose through 30 days post last dose.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
state: Colorado
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Siteman Cancer Center
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute/Tennessee Oncology
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
city: Sutton
country: United Kingdom
facility: The Royals Marsden NHS Foundation Trust
state: Surrey
Study officials:
References: