Status:
COMPLETED
GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer
Lead Sponsor:
Genome & Company
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05419362
Start Date
April 7 2022
End Date
August 26 2024
Last Update
December 16 2025
Active Locations (5)
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1
Ajou University Hospital
Gyeonggi-do, South Korea
2
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
3
Asan Medical Center
Seoul, South Korea
4
Samsung Medical Center
Seoul, South Korea