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New drug cocktail targets Hard-to-Treat cancers

NCT ID NCT05396833

Disease control Sponsor: EMD Serono Research & Development Institute, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new drug called tuvusertib, given together with either lartesertib or avelumab, in people with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see how the body processes the drugs. About 120 participants will take part across several groups, each focusing on different cancer types or drug combinations.

What this could mean

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

Active substance
Tuvusertib (M1774) combined with lartesertib or avelumab
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) trial focused on safety and dosing, not on proving the drugs work. Many drug combinations fail at this stage, and side effects may be significant.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

120 people

The number who actually took part.

Started

Jun 2022

Finished

Jul 2026

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: * Parts A1, A1.1, A1.2, A2, A3, and A2/3: Participants with metastatic or locally advanced unresectable solid tumors refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator, which may convey clinical benefit, or who cannot tolerate standard of care treatment * Parts A1.1 and A1.2: Triple negative breast cancer, epithelial ovarian cancer, castrate resistant prostate cancer, urothelial cancer, endometrial cancer, and colorectal cancer independent of mutation status. * Part A2: Participants with advanced prostate cancer whose tumor carries a genetic loss of function (LoF) mutation(s) in the gene ataxia telangiectasia mutated (ATM). No more than 3 prior lines of therapy for castrate resistant disease. Prior therapy must have included a taxane and a novel antiandrogen (example \[e.g.\] enzalutamide). * Part A3: Participants with advanced endometrial cancer whose tumor carries a genetic LoF mutation(s) in the gene AT-rich interaction domain 1A (ARID1A). Prior therapy must have included a platinum agent. Prior therapy must also have included a checkpoint inhibitor if the participant has mismatch repair (MMR)-deficient endometrial cancer. Note for Parts A2/A3: Participants with ATM LoF mutated prostate cancer and ARID1A LoF mutated endometrial cancer should be prioritized to the respective expansion arms instead of being enrolled in Part A1.1. The presence of ATM and ARID1A LoF mutations will be determined according to historic data collected prior to prescreening, generated by an assay with appropriate regulatory status, in either tumor or liquid biopsy. The Sponsor will confirm that mutations certified by historic data fulfil this definition. * Participants with eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, with estimated life expectancy of at least 3 months * Adequate hematological, hepatic, and renal function as defined in the protocol * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participants with any condition, including any uncontrolled disease state other than with metastatic or locally advanced unresectable solid tumors, that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation * Participants with a known additional malignancy that is progressing and/or requires active treatment * Participants with carcinomatous meningitis are excluded regardless of clinical stability * Participants with serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease, and/or other situations that may preclude adequate absorption of oral medications * Participants with organ transplantation, including allogeneic stem cell transplant * Other protocol defined exclusion criteria could apply

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma colorectal cancer endometrial cancer metastatic malignant neoplasm metastatic neoplasm Neoplasm Metastasis ovarian carcinoma prostate cancer triple-negative breast carcinoma urothelial carcinoma

As listed by the trial registrant

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

Metastatic or locally advanced unresectable solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Augusta University - formerly Georgia Regents University

    Augusta, Georgia, 30912, United States

  • Calvary Mater Newcastle - PARENT

    Waratah, Australia

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica

    Madrid, 28050, Spain

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona, Spain

  • Hospital QuironSalud Barcelona - Next Oncology

    Barcelona, 08023, Spain

  • Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I

    Madrid, Spain

  • Hospital Universitario Quironsalud Madrid - NEXT Oncology

    Madrid, 28223, Spain

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75230, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • Princess Margaret Cancer Centre

    Toronto, M5G 2C1, Canada

  • Providence Medical Foundation

    Santa Rosa, California, 95403, United States

  • Royal North Shore Hospital

    St Leonards, Australia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

    Seoul, 03722, South Korea

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66205, United States

  • University of Miami School of Medicine

    Miami, Florida, 33136, United States

  • University of Texas M. D. Anderson Cancer Center - Partner

    Houston, Texas, 77030, United States

More trials for these conditions

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