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

Non-small Cell Lung Cancer Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT04060342
• Other study ID #: GB1275-1101 (KEYNOTE-A36)
• Status: Terminated
• Phase: Phase 1
• Start date: August 13, 2019
• Est. completion date: April 11, 2022

Study information

• Verified date: August 2022
• Source: Gossamer Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• Castration-resistant Prostate Cancer
• Esophageal Adenocarcinoma
• Esophageal Squamous Cell Carcinoma
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Head and Neck Squamous Cell Carcinoma
• Hepatocellular Carcinoma
• Lung Neoplasms
• Microsatellite Stable Colorectal Cancer
• Non-small Cell Lung Cancer
• Pancreatic Adenocarcinoma
• Renal Cell Carcinoma
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms
• Urothelial Carcinoma

Intervention

Drug:
• GB1275
Oral
• nab-paclitaxel and gemcitabine
IV infusion
• pembrolizumab
IV infusion

Locations

Country	Name	City	State
United Kingdom	The Royals Marsden NHS Foundation Trust	Sutton	Surrey
United States	University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)	Aurora	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	The Sarah Cannon Research Institute/Tennessee Oncology	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Washington University School of Medicine - Siteman Cancer Center	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas
United States	UCSF Medical Center at Mission Bay	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)		Regimen A and B dose escalation Days 1-21, Regimen C dose escalation Days 8-36 days
Primary	Phase 1 Dose Escalation - Regimens A, B, and C and Phase 1 Expansion - Regimen B: Incidence of adverse events (AEs)		Regimen A and C from first dose through 30 days post last dose, Regimen B from first dose through 90 days post last dose
Primary	Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275	Maximum observed plasma concentration	From first dose through 30 days post last dose
Primary	Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275	Trough observed plasma concentration	From first dose through 30 days post last dose
Primary	Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275	Time of maximum observed plasma concentration	From first dose through 30 days post last dose
Primary	Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275	Terminal phase elimination half-life	From first dose through 30 days post last dose
Primary	Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275	Area under the plasma concentration-time curve	From first dose through 30 days post last dose
Primary	Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275	Oral clearance	From first dose through 30 days post last dose
Primary	Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR)	ORR defined as the proportion of subjects with best overall confirmed response (BOCR) of either a complete response (CR) or partial response (PR) as assessed by the Investigator based on RECIST v1.1	24 months
Secondary	Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275	Maximum observed plasma concentration	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Ctrough of GB1275	Trough observed plasma concentration	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Tmax of GB1275	Time of maximum observed plasma concentration	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: t1/2 of GB1275	Terminal phase elimination half-life	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275	Area under the plasma concentration-time curve	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275	Oral clearance	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine	Maximum observed plasma concentration	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine)	Time of maximum observed plasma concentration	From first dose through 30 days post last dose
Secondary	Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine	Area under the plasma concentration-time curve	From first dose through 30 days post last dose
Secondary	Phase 2 - Basket Cohorts 1, 2, and 3: Duration of Response (DOR)	DOR defined as time from date of objective response to first documented date of disease progression or death	24 months
Secondary	Phase 2 - Basket Cohorts 1, 2, and 3: Time to Response (TTR)	TTR defined as time from first dose to first date of objective response	24 months
Secondary	Phase 2 - Basket Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR)	CBR defined as proportion of subjects with confirmed CR, PR, or stable disease (SD) at six months.	6 months
Secondary	Phase 2 - Basket Cohorts 1, 2, and 3: Progression Free Survival (PFS)	PFS defined as time from first dose to first documented date of disease progression or death.	24 months
Secondary	Phase 2 - Basket Cohorts 1, 2, and 3: Time to Progression (TTP)	TTP defined as time from first dose to first documented date of disease progression.	24 months
Secondary	Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS)	OS defined as time from first dose to date of death.	24 months
Secondary	Phase 2 - Basket Cohorts 1, 2, and 3: Incidence of AEs		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.
Secondary	Phase 2 - Basket Cohort 1, 2 and 3: PK profile of GB1275		Basket Cohorts 1, 2, and 3 from first dose through 30 days post last dose.