Clinical trial NCT05419362: GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Genome & Company
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2022-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab
timeFrame: 1 years
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 1 years
measure: Incidence of Laboratory abnormalities
timeFrame: 1 years
measure: Duration of response (DoR)
timeFrame: 1 years
measure: Progression-free Survival (PFS)
timeFrame: 1 years
measure: Overall Survival (OS)
timeFrame: 1 years
Other outcomes:
measure: Microbiota
timeFrame: 1 years
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Samsung Medical Center
name: Jeeyun Lee
role: PRINCIPAL_INVESTIGATOR
References: