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Experimental combo for advanced tumors hits early hurdle

NCT ID NCT03968653

Disease control Sponsor: Debiopharm International SA 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested an oral drug called Debio 0123 combined with the chemotherapy carboplatin in 76 people with advanced solid tumors that had stopped responding to prior platinum-based treatments. The main goals were to find a safe dose and check for side effects. The trial was terminated early, so full results are not available.

What this could mean

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

Active substance
Debio 0123 (oral capsule) and carboplatin (IV infusion)
What this could lead to
If successful, this could point toward a new combination treatment for advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This was a very early (phase 1) trial that was terminated, so results are limited. The combination may cause significant side effects and may not shrink tumors effectively.

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

76 people

The number who actually took part.

Started

Jul 2019

Finished

Oct 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: Dose Escalation: * Histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available * Able and willing to undergo tumor biopsy * Prior platinum-based therapy (carboplatin or cisplatin). * Life expectancy of at least 3 months * ECOG PS 0-1 Dose Expansion: * Histologically or cytologically confirmed, recurrent solid tumors of selected types. * Participants must have progressed after at least 1 prior platinum-based line of therapy for advanced/metastatic disease. * Participants must be platinum resistant (defined as progression within 6 months of completion of their most recent platinum-based chemotherapy). Prior poly (ADP-ribose) polymerase (PARP) inhibitor therapy is allowed. Platinum-based therapy does not need to be the last treatment prior to study entry. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Documented progressive or recurrent disease according to RECIST 1.1 since the last anti-cancer therapy and prior to study entry * Able and willing to undergo tumor biopsy * ECOG PS 0-1 * Life expectancy of at least 3 months Exclusion Criteria: Dose Escalation and Dose Expansion: * History of other malignancies requiring active treatment in the last 6 months * Brain tumors and/or symptomatic brain metastases * Receiving other investigating agents * Presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites * Prior exposure to any WEE1 inhibitor

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumors

Contacts and locations

Locations

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Vall Hebrón, Unidad de Investigación en Terapia Molecular (UITM)

    Barcelona, 08035, Spain

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Leiden University Medical Center, Dept. of Clinical Oncology

    Leiden, 2333, Netherlands

  • Radboud university medical center

    Nijmegen, 6525, Netherlands

  • University Medical Center Groningen

    Groningen, 9713, Netherlands

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