GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05419362
• Other study ID #: [GNC] GEN001-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 7, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Genome & Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• GEN-001
The capsules taken by mouth once a daily. Each capsule will contain = 3x10^11 colony-forming units (CFU)
• Avelumab
800 mg given by intravenous (IV) infusion once every 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Genome & Company	Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiota	fecal samples will be collected for analysis	1 years
Primary	To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab	Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	1 years
Secondary	Incidence of Adverse Events	Assessed as per CTCAE v5.0	1 years
Secondary	Incidence of Laboratory abnormalities	Assessed as per CTCAE v5.0	1 years
Secondary	Duration of response (DoR)	Assessed according to RECIST v1.1	1 years
Secondary	Progression-free Survival (PFS)	Assessed according to RECIST v1.1	1 years
Secondary	Overall Survival (OS)		1 years