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

NCT07805252 | Recruiting Phase 1

• 2 other identifiers: 31380012026-525864-17-00
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 7

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

Conditions

Advanced Solid Tumors Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).

  To evaluate the safety and tolerability of ODM-216 to determine the maximum tolerated dose (MTD) if applicable or maximum feasible dose (MFD) if applicable.

  12 months

• Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).

  To identify one or two recommended Part 2 doses (RP2Ds) for subsequent confirmation as the optimal biological dose (OBD) in Part 2.

  22 months

Study Arms (1)

ODM-216

EXPERIMENTAL

ODM-216

Drug: ODM-216

Interventions

ODM-216 DRUG

ODM-216

ODM-216

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (7)

START Rioja - Hospital Universitario San Pedro

Logroño, La Rioja, 26006, Spain

RECRUITING

NEXT Oncology - Hospital Quironsalud Madrid

Madrid, Pozuelo de Alarcón - Madrid, 28223, Spain

RECRUITING

START Barcelona - HM Nou Delfos

Barcelona, 08023, Spain

RECRUITING

Clinica Universidad de Navarra - Madrid

Madrid, 28027, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz - START MADRID

Madrid, 28040, Spain

RECRUITING

START Madrid - CIOCC FM Sanchinarro

Madrid, 28050, Spain

RECRUITING

Clínica Universidad de Navarra. Pamplona

Pamplona, 31008, Spain

RECRUITING

Study Officials

• Study Director Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Central Study Contacts

Clinical Study Director Clinical Study Director

CONTACT

+358104261; clinicaltrials@orionpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 4, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 10, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)