Trial to Study the Safety, Pharmacokinetics and Preliminary Antitumour Activity of ODM-216 in Patients With Cancer

ClinicalTrials.gov ID

NCT07805252

Lead Sponsor

Orion Corporation, Orion PharmaINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

195Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

Sep 3, 2026Actual

Primary Completion Date

Jan 10, 2028Estimated

Completion Date

Jan 10, 2028Estimated

Official Title

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

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

• Advanced Solid Tumors Cancer

• ODM-216

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Orion Corporation, Orion PharmaINDUSTRY

tatiana.hernandez@start-barcelona.com+34932545030

iortegoz@unav.es+34948255400

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