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

September 3, 2026 updated by: Orion Corporation, Orion Pharma

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • START Barcelona - HM Nou Delfos
        • Principal Investigator:
          • Tatiana Hernandez
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz - START MADRID
        • Principal Investigator:
          • Manuel Pedregal
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • Clínica Universidad de Navarra. Pamplona
        • Contact:
        • Principal Investigator:
          • Ignacio Ortego
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Recruiting
        • START Rioja - Hospital Universitario San Pedro
        • Contact:
        • Principal Investigator:
          • Maria Demiguel
    • Pozuelo de Alarcón - Madrid
      • Madrid, Pozuelo de Alarcón - Madrid, Spain, 28223
        • Recruiting
        • NEXT Oncology - Hospital Quironsalud Madrid
        • Principal Investigator:
          • Valentina Boni
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ODM-216
Drug: ODM-216
ODM-216

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).
Time Frame: 8 days
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.
8 days
Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).
Time Frame: 22 months
To identify one or two recommended Part 2 doses (RP2Ds) for subsequent confirmation as the optimal biological dose (OBD) in Part 2.
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Study Director Clinical Study Director, Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2026

Primary Completion (Estimated)

January 10, 2028

Study Completion (Estimated)

January 10, 2028

Study Registration Dates

First Submitted

August 26, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 3138001
  • 2026-525864-17-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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