Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a new pill boost Immunotherapy's power against advanced tumors?

NCT ID NCT03674567

Disease control Sponsor: RAPT Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests an experimental drug called FLX475, given alone or with the immunotherapy pembrolizumab, in people with advanced cancers that have not responded to standard treatments. The study aims to find the safest dose and to see whether the combination can shrink tumors. Participants receive the drugs in two phases: first to establish safety, then to measure anti-tumor activity across several cancer types.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FLX475 (tivumecirnon) alone or in combination with pembrolizumab (KEYTRUDA)
What this could lead to
If it works, this could offer a new treatment option for people with advanced cancers that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial, so the drug may not prove effective or safe in a larger group. Side effects are possible, and the combination may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

323 people

The number who actually took part.

Started

Sep 2018

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies * Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical Hodgkin lymphoma * Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts) * Tumor available for biopsy Exclusion Criteria: * History of allergy or severe hypersensitivity to biologic agents * History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment * 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 symptoms of active pneumonitis * Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant * Active graft-versus-host disease

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

breast neoplasm cancer carcinoma of esophagus cervical cancer classic Hodgkin lymphoma gastric cancer head and neck squamous cell carcinoma lymphoma nasopharyngeal carcinoma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck transitional cell carcinoma triple-negative breast carcinoma urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078, United States

  • Chi Mei Meidcal Center

    Tainan, 71004, Taiwan

  • Chungbuk National University Hospital

    Taebuk, 28644, South Korea

  • City of Hope

    Duarte, California, 91010, United States

  • Comprehensive Hematology and Oncology, LLC

    St. Petersburg, Florida, 33709, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Georgetown - Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21231, United States

  • King Chulaongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Linear Clinical Research Limited

    Nedlands, Western Australia, 6009, Australia

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York, 10032, United States

  • Prince of Wales Hospital

    Shatin, Hong Kong

  • Quantum Santa Fe

    Santa Fe, New Mexico, 87505, United States

  • Queen Mary Hospital

    High West, Hong Kong

  • Queen Mary Hospital - Lymphoma

    High West, Hong Kong

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of California, Los Angeles JCCC Clinical Research Unit

    Los Angeles, California, 90024, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Louisville Hospital/James Graham Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.