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Monoclonal Antibodies

FLX475 + Pembrolizumab for Tumors/Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by RAPT Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (approximately 2 years)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, FLX475, either alone or in combination with another drug, pembrolizumab. The trial will have two parts, with the first part testing different doses of the new drug to see what is safe, and the second part testing the new drug in people with different types of cancer.

Who is the study for?
This trial is for adults with certain advanced cancers (like lung, breast, or lymphoma) who can't be helped by standard treatments. They should be fairly active and well (ECOG 0-1), have tumors that can be measured on scans, and a tumor sample available. People with severe past reactions to immune therapies, serious lung conditions, recent organ transplants, or active autoimmune diseases aren't eligible.Check my eligibility
What is being tested?
The study tests FLX475 alone and combined with pembrolizumab in two parts: first finding the right dose of FLX475 (dose escalation), then giving it to more people at this dose to see how well it works and how safe it is (cohort expansion).See study design
What are the potential side effects?
Possible side effects include those common to immunotherapies like fatigue, skin reactions, inflammation in organs such as lungs or intestines; also infusion-related reactions due to the body's response to receiving these drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate in subjects treated with FLX475 as a single agent and in combination with pembrolizumab
Safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab measured by the incidence of adverse events, including dose-limiting toxicities and maximum tolerated dose

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2b: Combination Expansion CohortsExperimental Treatment2 Interventions
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.
Group II: Part 2a: Monotherapy Expansion CohortsExperimental Treatment1 Intervention
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.
Group III: Part 1b: Combination Dose EscalationExperimental Treatment2 Interventions
Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
Group IV: Part 1a: Monotherapy Dose EscalationExperimental Treatment1 Intervention
Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
FLX475
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,248 Total Patients Enrolled
RAPT Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
535 Total Patients Enrolled
William Ho, MD, PhDStudy DirectorRAPT Therapeutics, Inc.
2 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

FLX475 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03674567 — Phase 1 & 2
Cancer Research Study Groups: Part 1a: Monotherapy Dose Escalation, Part 1b: Combination Dose Escalation, Part 2a: Monotherapy Expansion Cohorts, Part 2b: Combination Expansion Cohorts
Cancer Clinical Trial 2023: FLX475 Highlights & Side Effects. Trial Name: NCT03674567 — Phase 1 & 2
FLX475 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03674567 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical clinics is this study being conducted?

"To make it more convenient for patients, this trial is being conducted at 13 sites which are situated in major cities such as Louisville, Baltimore and Tampa. Additionally, there are other locations across the country. Selecting the site closest to you will help reduce travel-related burdens."

Answered by AI

FLX475 has undergone other medical research trials in the past, correct?

"FLX475 was first studied a decade ago, in 2010. Since then, there have been 249 completed trials. Presently, 1000 different clinical trials are recruiting patients with a sizable number of these studies based in Louisville, Kentucky."

Answered by AI

What are the primary FLX475 indications?

"FLX475 has demonstrated efficacy in the treatment of malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

How many people have signed up to participate in this research?

"In order to carry out the study, 375 people who meet the specific inclusion criteria set by the sponsor are needed. The trial will be conducted at multiple sites run by Merck Sharp & Dohme LLC, including University of Louisville Hospital/James Graham Brown Cancer Center in Louisville, Kentucky and Johns Hopkins University in Baltimore, Maryland."

Answered by AI

Are there any spots still available for people who want to participate in this clinical trial?

"Yes, as of now this clinical trial is still looking for willing participants. The listing was first posted on September 25th, 2018 and has been updated as recently as June 10th, 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
2018. "Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03674567.
~18 spots leftby Sep 2024
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