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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-13

Study Completion Date

2022-04-11

Brief Summary

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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

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Detailed Description

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

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Phase 1 - Dose Escalation of 3 different Regimens and Expansion, Phase 2 - Basket Expansion of 3 Cohorts

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1: Regimen A - GB1275 monotherapy

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

Group Type EXPERIMENTAL

GB1275

Intervention Type DRUG

Oral

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).

Group Type EXPERIMENTAL

GB1275

Intervention Type DRUG

Oral

pembrolizumab

Intervention Type DRUG

IV infusion

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)

Group Type EXPERIMENTAL

GB1275

Intervention Type DRUG

Oral

nab-paclitaxel and gemcitabine

Intervention Type DRUG

IV infusion

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.

Group Type EXPERIMENTAL

GB1275

Intervention Type DRUG

Oral

nab-paclitaxel and gemcitabine

Intervention Type DRUG

IV infusion

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).

Group Type EXPERIMENTAL

GB1275

Intervention Type DRUG

Oral

pembrolizumab

Intervention Type DRUG

IV infusion

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).

Group Type EXPERIMENTAL

GB1275

Intervention Type DRUG

Oral

pembrolizumab

Intervention Type DRUG

IV infusion

Interventions

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GB1275

Oral

Intervention Type DRUG

nab-paclitaxel and gemcitabine

IV infusion

Intervention Type DRUG

pembrolizumab

IV infusion

Intervention Type DRUG

Other Intervention Names

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Investigational Abraxane and Gemzar Anti-PD-1

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No