ODM-216 in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1/2, open-label trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ODM-216 in participants with advanced solid tumors. The study will assess preliminary antitumor activity and determine how the drug behaves in the body. Eligible patients have measurable disease, are refractory to standard therapies, and provide baseline tumor tissue for analysis. The trial is conducted at selected centers in Spain and requires informed consent and acceptable performance status.

Why it matters

Who can join: the full rules

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

Where it's running

• START Rioja - Hospital Universitario San Pedro
  Logroño, La Rioja, Spain Recruiting
• NEXT Oncology - Hospital Quironsalud Madrid
  Madrid, Pozuelo de Alarcón - Madrid, Spain Recruiting
• START Barcelona - HM Nou Delfos
  Barcelona, Spain Recruiting
• Clinica Universidad de Navarra - Madrid
  Madrid, Spain Recruiting
• Hospital Universitario Fundacion Jimenez Diaz - START MADRID
  Madrid, Spain Recruiting
• START Madrid - CIOCC FM Sanchinarro
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Clinical Study Director Clinical Study Director
• Email: clinicaltrials@orionpharma.com
• Phone: +358104261

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.