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

August 17, 2022 updated by: GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royals Marsden NHS Foundation Trust
  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Siteman Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute/Tennessee Oncology
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1: Regimen A - GB1275 monotherapy
GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).
Drug: GB1275
Oral
Other Names:
  • 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: pembrolizumab
IV infusion
Other Names:
  • Anti-PD-1
Drug: GB1275
Oral
Other Names:
  • Investigational
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 Names:
  • Investigational
Drug: nab-paclitaxel and gemcitabine
IV infusion
Other Names:
  • 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 Names:
  • Investigational
Drug: nab-paclitaxel and gemcitabine
IV infusion
Other Names:
  • 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: pembrolizumab
IV infusion
Other Names:
  • Anti-PD-1
Drug: GB1275
Oral
Other Names:
  • Investigational
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: pembrolizumab
IV infusion
Other Names:
  • Anti-PD-1
Drug: GB1275
Oral
Other Names:
  • Investigational

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Regimen A and B dose escalation Days 1-21, Regimen C dose escalation Days 8-36 days
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
Regimen A and C from first dose through 30 days post last dose, Regimen B from first dose through 90 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
From first dose through 30 days post last dose
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
24 months
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
24 months
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.
6 months
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.
24 months
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.
24 months
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.
24 months
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.
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.
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.
Basket Cohorts 1, 2, and 3 from first dose through 30 days post last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GB1275-1101 (KEYNOTE-A36)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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