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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

Primary Purpose

Pancreatic Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GB1275
nab-paclitaxel and gemcitabine
pembrolizumab
Sponsored by
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Medical Center at Mission Bay
  • University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
  • Washington University School of Medicine - Siteman Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Duke University Medical Center
  • The Sarah Cannon Research Institute/Tennessee Oncology
  • South Texas Accelerated Research Therapeutics, LLC
  • The Royals Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1: Regimen A - GB1275 monotherapy

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

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

Phase 2: Cohort 1 - GB1275 with SOC

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

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

Arm Description

GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).

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

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

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 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).

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).

Outcomes

Primary Outcome Measures

Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)
Phase 1 Dose Escalation - Regimens A, B, and C and Phase 1 Expansion - Regimen B: Incidence of adverse events (AEs)
Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275
Maximum observed plasma concentration
Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275
Trough observed plasma concentration
Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275
Time of maximum observed plasma concentration
Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275
Terminal phase elimination half-life
Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275
Area under the plasma concentration-time curve
Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275
Oral clearance
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

Secondary Outcome Measures

Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275
Maximum observed plasma concentration
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Ctrough of GB1275
Trough observed plasma concentration
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Tmax of GB1275
Time of maximum observed plasma concentration
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: t1/2 of GB1275
Terminal phase elimination half-life
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275
Area under the plasma concentration-time curve
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275
Oral clearance
Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine
Maximum observed plasma concentration
Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine)
Time of maximum observed plasma concentration
Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine
Area under the plasma concentration-time curve
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
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
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.
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.
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.
Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS)
OS defined as time from first dose to date of death.
Phase 2 - Basket Cohorts 1, 2, and 3: Incidence of AEs
Phase 2 - Basket Cohort 1, 2 and 3: PK profile of GB1275

Full Information

First Posted
August 9, 2019
Last Updated
August 17, 2022
Sponsor
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04060342
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Phase 1 - Dose Escalation of 3 different Regimens and Expansion, Phase 2 - Basket Expansion of 3 Cohorts
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Regimen A - GB1275 monotherapy
Arm Type
Experimental
Arm Description
GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).
Arm Title
Phase 1: Regimen B - GB1275 with an Anti-PD-1
Arm Type
Experimental
Arm Description
GB1275 with pembrolizumab dose escalation and expansion: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).
Arm Title
Phase 1: Regimen C - GB1275 with Standard of Care (SOC)
Arm Type
Experimental
Arm Description
GB1275 with SOC dose escalation: GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI)
Arm Title
Phase 2: Cohort 1 - GB1275 with SOC
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2: Cohort 2 - GB1275 with an Anti-PD-1
Arm Type
Experimental
Arm Description
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).
Arm Title
Phase 2: Cohort 3 - GB1275 with an Anti-PD-1
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
GB1275
Other Intervention Name(s)
Investigational
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel and gemcitabine
Other Intervention Name(s)
Abraxane and Gemzar
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
pembrolizumab
Other Intervention Name(s)
Anti-PD-1
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
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
Title
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
Title
Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275
Description
Maximum observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275
Description
Trough observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275
Description
Time of maximum observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275
Description
Terminal phase elimination half-life
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275
Description
Area under the plasma concentration-time curve
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275
Description
Oral clearance
Time Frame
From first dose through 30 days post last dose
Title
Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR)
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275
Description
Maximum observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Ctrough of GB1275
Description
Trough observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Tmax of GB1275
Description
Time of maximum observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: t1/2 of GB1275
Description
Terminal phase elimination half-life
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275
Description
Area under the plasma concentration-time curve
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275
Description
Oral clearance
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine
Description
Maximum observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine)
Description
Time of maximum observed plasma concentration
Time Frame
From first dose through 30 days post last dose
Title
Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine
Description
Area under the plasma concentration-time curve
Time Frame
From first dose through 30 days post last dose
Title
Phase 2 - Basket Cohorts 1, 2, and 3: Duration of Response (DOR)
Description
DOR defined as time from date of objective response to first documented date of disease progression or death
Time Frame
24 months
Title
Phase 2 - Basket Cohorts 1, 2, and 3: Time to Response (TTR)
Description
TTR defined as time from first dose to first date of objective response
Time Frame
24 months
Title
Phase 2 - Basket Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR)
Description
CBR defined as proportion of subjects with confirmed CR, PR, or stable disease (SD) at six months.
Time Frame
6 months
Title
Phase 2 - Basket Cohorts 1, 2, and 3: Progression Free Survival (PFS)
Description
PFS defined as time from first dose to first documented date of disease progression or death.
Time Frame
24 months
Title
Phase 2 - Basket Cohorts 1, 2, and 3: Time to Progression (TTP)
Description
TTP defined as time from first dose to first documented date of disease progression.
Time Frame
24 months
Title
Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS)
Description
OS defined as time from first dose to date of death.
Time Frame
24 months
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington University School of Medicine - Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Sarah Cannon Research Institute/Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The Royals Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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