We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GB1275-1101
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060342
Recruitment Status : Terminated (No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.)
First Posted : August 19, 2019
Last Update Posted : August 18, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. )

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

Condition or disease Intervention/treatment Phase
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 Drug: GB1275 Drug: nab-paclitaxel and gemcitabine Drug: pembrolizumab Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1 - Dose Escalation of 3 different Regimens and Expansion, Phase 2 - Basket Expansion of 3 Cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 13, 2019
Actual Primary Completion Date : April 11, 2022
Actual Study Completion Date : April 11, 2022


Arm Intervention/treatment
Experimental: Phase 1: Regimen A - GB1275 monotherapy
GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).
Drug: GB1275
Oral
Other Name: Investigational

Experimental: Phase 1: Regimen B - GB1275 with an Anti-PD-1

GB1275 with pembrolizumab dose escalation and expansion:

GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).

Drug: GB1275
Oral
Other Name: Investigational

Drug: pembrolizumab
IV infusion
Other Name: Anti-PD-1

Experimental: Phase 1: Regimen C - GB1275 with Standard of Care (SOC)

GB1275 with SOC dose escalation:

GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI)

Drug: GB1275
Oral
Other Name: Investigational

Drug: nab-paclitaxel and gemcitabine
IV infusion
Other Name: Abraxane and Gemzar

Experimental: Phase 2: Cohort 1 - GB1275 with SOC

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.

Drug: GB1275
Oral
Other Name: Investigational

Drug: nab-paclitaxel and gemcitabine
IV infusion
Other Name: Abraxane and Gemzar

Experimental: Phase 2: Cohort 2 - GB1275 with an Anti-PD-1

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).

Drug: GB1275
Oral
Other Name: Investigational

Drug: pembrolizumab
IV infusion
Other Name: Anti-PD-1

Experimental: Phase 2: Cohort 3 - GB1275 with an Anti-PD-1

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).

Drug: GB1275
Oral
Other Name: Investigational

Drug: pembrolizumab
IV infusion
Other Name: Anti-PD-1




Primary Outcome Measures :
  1. Phase 1 Dose Escalation - 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 escalation Days 8-36 days ]
  2. Phase 1 Dose Escalation - Regimens A, B, and C and Phase 1 Expansion - Regimen B: Incidence of adverse events (AEs) [ Time Frame: Regimen A and C from first dose through 30 days post last dose, Regimen B from first dose through 90 days post last dose ]
  3. Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Maximum observed plasma concentration

  4. Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Trough observed plasma concentration

  5. Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Time of maximum observed plasma concentration

  6. Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Terminal phase elimination half-life

  7. Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Area under the plasma concentration-time curve

  8. Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Oral clearance

  9. Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR) [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Maximum observed plasma concentration

  2. Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Ctrough of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Trough observed plasma concentration

  3. Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Tmax of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Time of maximum observed plasma concentration

  4. Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: t1/2 of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Terminal phase elimination half-life

  5. Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Area under the plasma concentration-time curve

  6. Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275 [ Time Frame: From first dose through 30 days post last dose ]
    Oral clearance

  7. Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine [ Time Frame: From first dose through 30 days post last dose ]
    Maximum observed plasma concentration

  8. Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine) [ Time Frame: From first dose through 30 days post last dose ]
    Time of maximum observed plasma concentration

  9. Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine [ Time Frame: From first dose through 30 days post last dose ]
    Area under the plasma concentration-time curve

  10. Phase 2 - Basket Cohorts 1, 2, and 3: Duration of Response (DOR) [ Time Frame: 24 months ]
    DOR defined as time from date of objective response to first documented date of disease progression or death

  11. Phase 2 - Basket Cohorts 1, 2, and 3: Time to Response (TTR) [ Time Frame: 24 months ]
    TTR defined as time from first dose to first date of objective response

  12. Phase 2 - Basket Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR) [ Time Frame: 6 months ]
    CBR defined as proportion of subjects with confirmed CR, PR, or stable disease (SD) at six months.

  13. Phase 2 - Basket Cohorts 1, 2, and 3: Progression Free Survival (PFS) [ Time Frame: 24 months ]
    PFS defined as time from first dose to first documented date of disease progression or death.

  14. Phase 2 - Basket Cohorts 1, 2, and 3: Time to Progression (TTP) [ Time Frame: 24 months ]
    TTP defined as time from first dose to first documented date of disease progression.

  15. Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS) [ Time Frame: 24 months ]
    OS defined as time from first dose to date of death.

  16. Phase 2 - Basket Cohorts 1, 2, and 3: Incidence of AEs [ Time Frame: 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. ]
  17. Phase 2 - Basket Cohort 1, 2 and 3: PK profile of GB1275 [ Time Frame: Basket Cohorts 1, 2, and 3 from first dose through 30 days post last dose. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060342


Locations
Layout table for location information
United States, California
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States, 80045
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Tennessee
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
United Kingdom
The Royals Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Merck Sharp & Dohme LLC
Layout table for additonal information
Responsible Party: GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT04060342    
Other Study ID Numbers: GB1275-1101 (KEYNOTE-A36)
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gossamer Bio Inc. ( GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. ):
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Lung Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Squamous Cell
Breast Neoplasms
Breast Diseases
Skin Diseases
Head and Neck Neoplasms
Esophageal Neoplasms
Esophageal Diseases
Gemcitabine