FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04768686
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 90
• Locations: 10
• Arm: 1
• Anticipated Duration (Months): 54.5
• Patients Per Site: 9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. This study is designed to assess the potential anti-tumor activity when administered at the 100mg QD of FLX475 with pembrolizumab and will be conducted (2) cohorts as detailed below.

• Cohort 1: EBV negative / CPI naïve gastric cancer subjects who have progressed on at least 2 prior systemic treatments for advanced or metastatic gastric cancer

• Cohort 2: EBV positive / CPI naïve gastric cancer subjects who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: FLX475; Drug: Pembrolizumab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study to Assess the Safety, Efficacy of FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer
• Actual Study Start Date: May 18, 2021
• Anticipated Primary Completion Date: Nov 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: FLX475 and pembrolizumab combination therapy Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

Drug: FLX475; tablet; Drug: Pembrolizumab; IV infusion; Other Names: Keytruda

Outcome Measures

Primary Outcome Measures

1. Overall response rate in subjects treated with FLX475 in combination with pembrolizumab [Through study completion (approximately 2 years)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma

• Patient must have one of the following diagnoses to be eligible for enrollment into cohorts:

• Cohort 1: Checkpoint inhibitor naïve Epstein-Barr Virus negative (EBV-) gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer

• Cohort 2: Checkpoint inhibitor naïve Epstein-Barr virus positive (EBV+) gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

• Patient must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI)

• Tumor available for biopsy

Exclusion Criteria:

• Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), any history of discontinuing from that treatment due to Grade 3 or higher immune-related adverse event (irAE)

• Patient with MSI-H status

• Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or clinical symptoms of active pneumonitis

• Significant cardiovascular disease. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or chronic Grade 3 hypertension.

• Significant screening electrocardiogram (ECG) abnormalities

• Has had an allogenic tissue/solid organ transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanllym University Medical Center	Anyang-si	Gyeonggi-do	Korea, Republic of
2	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of
3	The Catholic University of Korea St. Vincent Hospital	Suwon-si,	Gyeonggi-do	Korea, Republic of
4	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do	Korea, Republic of
5	Asan Medical Center	Seoul		Korea, Republic of
6	Gangnam Severance Hospital	Seoul		Korea, Republic of
7	Korea University Guro Hospital	Seoul		Korea, Republic of
8	Samsung Medical Center	Seoul		Korea, Republic of
9	Seoul National University Hospital	Seoul		Korea, Republic of
10	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited
• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT04768686
• Other Study ID Numbers: HM-CCRI-201; KEYNOTE-B83; MK3475-B83
• First Posted: Feb 24, 2021
• Last Update Posted: Apr 28, 2022
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Stomach Neoplasms; Pembrolizumab

Study Results

No Results Posted as of Apr 28, 2022