Can a new pill shrink advanced solid tumors?
NCT ID NCT07805252
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 195 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Clínica Universidad de Navarra. Pamplona
RECRUITINGPamplona, 31008, Spain
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Hospital Universitario Fundacion Jimenez Diaz - START MADRID
RECRUITINGMadrid, 28040, Spain
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NEXT Oncology - Hospital Quironsalud Madrid
RECRUITINGMadrid, Pozuelo de Alarcón - Madrid, 28223, Spain
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START Barcelona - HM Nou Delfos
RECRUITINGBarcelona, 08023, Spain
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START Rioja - Hospital Universitario San Pedro
RECRUITINGLogroño, La Rioja, 26006, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
- Can a new gemcitabine formulation outsmart advanced solid tumors?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can a Two-Pronged drug attack Hard-to-Treat tumors?