Clinical Trials /

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

NCT04060342

Description:

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

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Breast Carcinoma
  • Colorectal Adenocarcinoma
  • Colorectal Carcinoma
  • Esophageal Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma
  • Gastric Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: GB1275-1101
  • NCT ID: NCT04060342

Conditions

  • 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

Interventions

DrugSynonymsArms
GB1275InvestigationalPhase 1: Regimen A - GB1275 monotherapy
nab-paclitaxel and gemcitabineAbraxane and GemzarPhase 1: Regimen C - GB1275 with Standard of Care (SOC)
pembrolizumabAnti-PD-1Phase 1: Regimen B - GB1275 with an Anti-PD-1

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Phase 1: Regimen A - GB1275 monotherapyExperimentalGB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).
  • GB1275
Phase 1: Regimen B - GB1275 with an Anti-PD-1ExperimentalGB1275 with pembrolizumab dose escalation: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).
  • GB1275
  • pembrolizumab
Phase 1: Regimen C - GB1275 with Standard of Care (SOC)ExperimentalGB1275 with SOC dose escalation: GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI)
  • GB1275
  • nab-paclitaxel and gemcitabine
Phase 2: Cohort 1 - GB1275 with SOCExperimentalGB1275 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.
  • GB1275
  • nab-paclitaxel and gemcitabine
Phase 2: Cohort 2 - GB1275 with an Anti-PD-1ExperimentalGB1275 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).
  • GB1275
  • pembrolizumab
Phase 2: Cohort 3 - GB1275 with an Anti-PD-1ExperimentalGB1275 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).
  • GB1275
  • pembrolizumab

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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Maximum observed plasma concentration

Secondary Outcome Measures

Measure:Phase 1 - Regimen C: Cmax of GB1275
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Maximum observed plasma concentration
Measure:Phase 1 - Regimen C: Ctrough of GB1275
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Trough observed plasma concentration
Measure:Phase 1 - Regimen C: Tmax of GB1275
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Time of maximum observed plasma concentration
Measure:Phase 1 - Regimen C: t1/2 of GB1275
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Terminal phase elimination half-life
Measure:Phase 1 - Regimen C: AUC of GB1275
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Area under the plasma concentration-time curve
Measure:Phase 1 - Regimen C: CL/F of GB1275
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Oral clearance
Measure:Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Maximum observed plasma concentration
Measure:Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine)
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Time of maximum observed plasma concentration
Measure:Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine
Time Frame:From baseline through 30 days last dose
Safety Issue:
Description:Area under the plasma concentration-time curve
Measure:Phase 2 - Expansion Cohorts 1, 2, and 3: Duration of Response (DOR)
Time Frame:24 months
Safety Issue:
Description:DOR defined as time from date of objective response to first documented date of disease progression or death
Measure:Phase 2 - Expansion Cohorts 1, 2, and 3: Time to Response (TTR)
Time Frame:24 months
Safety Issue:
Description:TTR defined as time from first dose to first date of objective response
Measure:Phase 2 - Expansion Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR)
Time Frame:6 months
Safety Issue:
Description:CBR defined as proportion of subjects with confirmed CR, PR, or stable disease (SD) at six months.
Measure:Phase 2 - Expansion Cohorts 1, 2, and 3: Progression Free Survival (PFS)
Time Frame:24 months
Safety Issue:
Description:PFS defined as time from first dose to first documented date of disease progression or death.
Measure:Phase 2 - Expansion Cohorts 1, 2, and 3: Time to Progression (TTP)
Time Frame:24 months
Safety Issue:
Description:TTP defined as time from first dose to first documented date of disease progression.
Measure:Phase 2 - Expansion Cohorts 1, 2, and 3: Overall Survival (OS)
Time Frame:24 months
Safety Issue:
Description:OS defined as time from first dose to date of death.
Measure: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.
Safety Issue:
Description:
Measure: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.
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Trial Keywords

  • GEJ adenocarcinoma
  • TNBC
  • MSS mCRC
  • PD-L1 + gastric cancer
  • PD-L1 positive gastric cancer

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