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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

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ClinicalTrials.gov Identifier: NCT04060342
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
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 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 Drug: GB1275 Drug: nab-paclitaxel and gemcitabine Drug: pembrolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1 - Dose Escalation of 3 different Regimen Phase 2 - Dose 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 : July 25, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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:

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 Cohort Expansion 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 Cohort Expansion 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 Cohort Expansion 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 - 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 escalations Days 1-36 days ]
  2. Phase 1 - Regimens A, B,and C: Incidence of adverse events (AEs) [ Time Frame: Regimen A, B, and C dose escalation from baseline through 30 days last dose ]
  3. Phase 1 - Regimens A and B: Cmax of GB1275 [ Time Frame: From baseline through 30 days last dose ]
    Maximum observed plasma concentration

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

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

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

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

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

  9. Phase 2 - Expansion 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: Cmax of GB1275 [ Time Frame: From baseline through 30 days last dose ]
    Maximum observed plasma concentration

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

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

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

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

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

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

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

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

  10. Phase 2 - Expansion 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 - Expansion 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 - Expansion 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 - Expansion 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 - Expansion 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 - Expansion 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 - Expansion Cohorts 1, 2, and 3: Incidence of AEs [ Time Frame: Cohorts 1, 2 and 3 dose expansion from baseline through 30 days last dose. ]
  17. Phase 2 - Expansion Cohort 1, 2 and 3: PK profile of GB1275 [ Time Frame: Cohorts 1, 2, and 3 dose expansion from baseline through 30 days last dose. ]


Information from the National Library of Medicine

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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
  • Regimen C: 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


Contacts
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Contact: GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. 1-866-668-4083 ClinicalTrials@gossamerbio.com

Locations
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United States, Tennessee
The Sarah Cannon Research Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

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Responsible Party: GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT04060342     History of Changes
Other Study ID Numbers: GB1275-1101
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Adenocarcinoma
Triple Negative Breast Neoplasms
Esophageal Squamous Cell Carcinoma
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Breast Neoplasms
Breast Diseases
Skin Diseases
Esophageal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Pembrolizumab
Antibodies
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators