Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* 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

FLX475

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.

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

A Phase 2 Study to Assess the Safety, Efficacy of FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer

Merck Sharp & Dohme LLC

Hanmi Pharmaceutical Company Limited

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Ipilimumab

Participants received FLX475 tablets orally and ipilimumab by IV infusions

William Ho, MD, PhD

This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent.

The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.

FLX475 in Combination With Ipilimumab in Advanced Melanoma

Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma

To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent

Number of participants that experienced Other Adverse Events

Number of participants that experienced Serious Adverse Events

To evaluate the progression-free survival (PFS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent

To evaluate the overall survival (OS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent

To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab

To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action

To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab

RAPT Therapeutics, Inc.

Adverse events were reported by the sites into an electronic data capture system

Participants received FLX475 tablets orally and ipilimumab by IV infusions

FLX475: Tablet

Ipilimumab: IV infusion

FLX475 and Ipilimumab Combination Therapy

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The study was terminated early due to changes in the treatment landscape of melanoma that have occurred since the initiation of the study, leading to small numbers of subjects analyzed.

William Ho

This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety,

Objective Response Rate

Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events

This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety.

Progression-free Survival

All participants who received the study drug

Overall Survival (OS)

Plasma Concentrations of FLX475

Pharmacodynamic (PD) Markers

Tumor Control

Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Breast Neoplasms

Lymphoma

Uterine Cervical Neoplasms

Carcinoma, Transitional Cell

Nasopharyngeal Carcinoma

Lymphosarcoma

Transitional Cell Carcinoma

Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.

Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.

Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2.

Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2.

pembrolizumab (KEYTRUDA®)

This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer	NCT04768686	Gastric Cancer	FLX475 Pembrolizumab	18 Years -	Hanmi Pharmaceutical Company Limited
FLX475 in Combination With Ipilimumab in Advanced Melanoma	NCT04894994	Advanced Melano...	FLX475 Ipilimumab	18 Years -	RAPT Therapeutics, Inc.
FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer	NCT04768686	Gastric Cancer	FLX475 Pembrolizumab	18 Years -	Hanmi Pharmaceutical Company Limited
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab	NCT03674567	Advanced Cancer	FLX475 pembrolizumab (...	18 Years -	RAPT Therapeutics, Inc.

Spots Global Cancer Trial Database for flx475

Every month we try and update this database with for flx475 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flx475

Every month we try and update this database with for flx475 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flx475 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.