Clinical trial · Interventional
GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer
A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
| GEN-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GEN-001 with avelumab
- description
- 42 patients in total with metastatic GC/Gastroesophageal Junction Adenocarcinoma who have progressed after 2 prior systemic treatments and confirmed PD-L1 positive expression will be enrolled in this study.
- interventionNames
- Drug: GEN-001
- Drug: Avelumab
Primary outcomes (1)
- measure
- To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab
- timeFrame
- 1 years
- description
- Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary outcomes (5)
- measure
- Incidence of Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unresectable, recurrent, locally advanced or metastatic GC/Gastroesophageal Junction Adenocarcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have adequate organ functions as defined in the protocol * Negative childbearing potential * Have experienced documented objective radiographic or clinical disease progression after 2 or above previous lines of standard therapy. * PD-L1 positive * Measurable disease as per RECIST v1.1 defined as at least 1 lesion * Estimated life expectancy of at least 3 months * Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities Exclusion Criteria: * Previously received T-cell coregulatory protein inhibitors * Has clinically significant evidence of ascites by physical exam * Known prior severe hypersensitivity reactions to monoclonal antibodies or any component in their formulation * Has active autoimmune disease that has required systemic treatment in the past 2 years * Current use of immunosuppressive medication * Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within 4 weeks * Has received a live vaccine within 4 weeks * Known history or any evidence of active for non-infectious pneumonitis * Prior solid organ or allogeneic stem cell transplantation * Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks * Has received proton pump inhibitors (PPIs) within 2 weeks * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has clinically significant (i.e., active) cardiovascular disease * Has other persisting toxicities * Has other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, or psychiatric conditions
References
Publications (0)
Data not yet available