Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.
Summary
Brief summary (as posted)
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
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GB1275 | Drug | — | UNRESOLVED |
| nab-paclitaxel and gemcitabine | Drug | — | UNRESOLVED |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Phase 1: Regimen A - GB1275 monotherapy
- description
- GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).
- interventionNames
- Drug: GB1275
- type
- EXPERIMENTAL
- label
- Phase 1: Regimen B - GB1275 with an Anti-PD-1
- description
- GB1275 with pembrolizumab dose escalation and expansion: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).
- interventionNames
- Drug: GB1275
- Drug: pembrolizumab
- type
- EXPERIMENTAL
- label
- Phase 1: Regimen C - GB1275 with Standard of Care (SOC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available