Can a new pill shrink advanced solid tumors?

NCT ID NCT07805252

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests an experimental drug called ODM-216 in adults with advanced solid tumors, which are cancers that have spread or cannot be removed by surgery. The study has two parts: the first finds a safe dose, and the second checks how well that dose fights the cancer. Researchers measure side effects, how the drug moves through the body, and whether tumors shrink. The goal is to see if ODM-216 is safe enough and promising enough to study further.

What this could mean

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

Active substance
ODM-216, an experimental drug taken by mouth
What this could lead to
If ODM-216 proves safe and effective, it could become a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early, first-in-human trial, so the drug may not work as hoped or may cause side effects. The results will only show preliminary activity, not a proven benefit.

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

About 195 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

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.

Key Eligibility Requirements. A participant must: 1. Understand the trial procedures and agree to participate by giving written, signed, and dated informed consent (IC; or witness consent). 2. Male or female participants ≥18 years old. 3. Have a performance status of 0 or 1 on the ECOG performance scale. 4. Participants must be willing and able to undergo a baseline tumour biopsy; for further information please refer to protocol. 6\. Participants must have a histologically or cytologically confirmed advanced solid malignancy and be refractory to or intolerant to established standard of care therapies known to provide clinical benefit as determined by the investigator. 7\. Participants must have measurable disease per RECIST v1.1, including at least one lesion that is measurable and appropriate for response evaluation. Lesions within a previously irradiated field are permissible as measurable disease provided that clear radiologic progression has been demonstrated and accurate measurement is feasible. 8\. Refer to the protocol for the full list of inclusion criteria Exclusion Criteria 1. Received prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 21 days; or immunotherapy or definitive/curative intent radiation therapy within 28 days, before receiving their first dose of ODM-216. 2. Have an autoimmune disease that has required systemic treatment in the past 2 years (i.e. use of disease modifying agents, high dose corticosteroids, or immunosuppressive drugs). 3. Brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the first dose of trial treatment. These should be previously treated and shown to be stable for at least 3 months post treatment. 4. Refer to the protocol for the full list of exclusion criteria

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clínica Universidad de Navarra. Pamplona

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital Universitario Fundacion Jimenez Diaz - START MADRID

    RECRUITING

    Madrid, 28040, Spain

  • NEXT Oncology - Hospital Quironsalud Madrid

    RECRUITING

    Madrid, Pozuelo de Alarcón - Madrid, 28223, Spain

  • START Barcelona - HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

  • START Rioja - Hospital Universitario San Pedro

    RECRUITING

    Logroño, La Rioja, 26006, Spain

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