Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug combo targets Hard-to-Treat cancers

NCT ID NCT04497116

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new oral drug called RP-3500 (camonsertib), alone or combined with talazoparib or gemcitabine, in 276 adults with advanced solid tumors that have certain genetic mutations. The main goals were to find the safest dose and check for early signs of tumor shrinkage. The trial is now complete, and results will help guide future studies.

What this could mean

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

Active substance
RP-3500 (camonsertib), talazoparib, gemcitabine
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have certain genetic changes.
What could go wrong
This is an early-phase trial focused on safety and dosing, not yet proven to work. The drugs may cause side effects, and the benefit for patients is uncertain.

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

276 people

The number who actually took part.

Started

Jul 2020

Finished

Jun 2025

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: * Written informed consent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses. * Male or female and ≥ 18 years-of-age at the time of signature of the consent. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy. * Measurable disease as per RECIST v1.1 * Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a certified lab per institutional guidelines: * Available tumor tissue * Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments. * Ability to swallow and retain oral medications. * Acceptable organ function at screening * Acceptable blood counts at screening * Negative pregnancy test (serum) for females of childbearing potential at Screening and prior to first study drug. * Resolution of all toxicities of prior treatment or surgery. * Male patients with female partners of childbearing potential and females of childbearing potential must follow a contraception method (oral contraceptives allowed) during their participation in the study and for at least 6 months following last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study and for 6 months following last dose of study drug. * Life expectancy ≥12 weeks after the start of the treatment according to the investigator's judgment. * Module 1c only: Ability to consume a high-fat meal and fast for 12 hours. Exclusion Criteria: * Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 14 days prior to first dose of study drug. * History or current condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment. * Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor. * Known hypersensitivity to any of the ingredients of RP-3500 (camonsertib). * Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the patient's safety. * Uncontrolled, symptomatic brain metastases. * Uncontrolled high blood pressure * Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. * Moderate or severe hepatic impairment (ie, Child-Pugh class B or C). * History or presence of an abnormal ECG that is clinically significant in the investigator's opinion. * History of ventricular dysrhythmias or risk factors such as structural heart disease, coronary heart disease (clinically significant electrolyte abnormalities or family history of sudden unexplained death or long QT syndrome * Current treatment with medications that are well-known to prolong the QT interval * History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis * Module 3 only: Known sensitivity to any of the ingredients of talazoparib.

Get updates

Get notified about this study

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

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • #1001, The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • #1002, Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • #1003, Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • #1004, Memorial Sloan Kettering Cancer Institute

    New York, New York, 10065, United States

  • #1005, Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • #1006, Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • #1007, Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • #1014, Northwestern University

    Chicago, Illinois, 60611, United States

  • #2001, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • #3001, The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • #3002, Freeman Hospital Newcastle

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • #3003, Sarah Cannon Research Institute

    London, W1G 6AD, United Kingdom

  • #4001, Copenhagen University Hospital Rigshospitalet - Blegdamsvej

    Copenhagen, DK, 2100 Ø, Denmark

More trials for these conditions

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