NCT07805252 Trial to Study the Safety, Pharmacokinetics and Preliminary Antitumour Activity of ODM-216 in Patients With Cancer
| NCT ID | NCT07805252 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Orion Corporation, Orion Pharma |
| Condition | Advanced Solid Tumors Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 195 participants |
| Start Date | 2026-09-03 |
| Primary Completion | 2028-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 195 participants in total. It began in 2026-09-03 with a primary completion date of 2028-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 1/2, Open-Label, First-in-Human Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumour Activity of ODM-216 in Participants With Advanced Solid Tumours
Eligibility Criteria
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
Contact & Investigator
Study Director Clinical Study Director
STUDY DIRECTOR
Orion Corporation, Orion Pharma
Frequently Asked Questions
Who can join the NCT07805252 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07805252 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07805252 currently recruiting?
Yes, NCT07805252 is actively recruiting participants. Contact the research team at clinicaltrials@orionpharma.com for enrollment information.
Where is the NCT07805252 trial being conducted?
This trial is being conducted at Logroño, Spain, Madrid, Spain, Barcelona, Spain, Madrid, Spain and 1 additional location.
Who is sponsoring the NCT07805252 clinical trial?
NCT07805252 is sponsored by Orion Corporation, Orion Pharma. The principal investigator is Study Director Clinical Study Director at Orion Corporation, Orion Pharma. The trial plans to enroll 195 participants.
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