Advanced Solid Tumors CancerPhase 1/2BICIDESNCT07805252
Trial to Study the Safety, Pharmacokinetics and Preliminary Antitumour Activity of ODM-216 in Patients With Cancer
A Phase 1/2 study testing ODM-216 in people with Advanced Solid Tumors Cancer, run by Orion Corporation, Orion Pharma at 7 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors Cancer
- What is being tested?
- ODM-216
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 7 sitesSpain
- Study dates
- 3 Sep 2026to 10 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
- Refer to the protocol for the full list of exclusion criteria
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
START Barcelona - HM Nou Delfos
Barcelona, 08023
Tatiana Hernandez, +34932545030, tatiana.hernandez@start-barcelona.com
Tatiana Hernandez
- Recruiting
START Rioja - Hospital Universitario San Pedro
Logroño, La Rioja, 26006
Maria Demiguel, +34941278760, maria.demiguel@startrioja.com
Maria Demiguel
- Recruiting
NEXT Oncology - Hospital Quironsalud Madrid
Madrid, Pozuelo de Alarcón - Madrid, 28223
Valentina Boni, +34914521900, vboni@nextoncology.eu
Valentina Boni
- Recruiting
Clinica Universidad de Navarra - Madrid
Madrid, 28027
Ignacio Ortego Zabalza, +34 948 255 400, iortegoz@unav.es
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz - START MADRID
Madrid, 28040
Manuel Pedregal, +34915504800, manuel.pedregal@startmadrid.com
Manuel Pedregal
- Recruiting
START Madrid - CIOCC FM Sanchinarro
Madrid, 28050
Irene Moreno Principal Investigator, +34 917567825, Irene.moreno@startmadrid.com
Irene Moreno
- Recruiting
Clínica Universidad de Navarra. Pamplona
Pamplona, 31008
Ignacio Ortego, +34948255400, iortegoz@unav.es
Ignacio Ortego
About this study
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
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
- Being tested
- ODM-216
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-216Drug
ODM-216
| Study group | Role | What they receive |
|---|---|---|
| ODM-216 | Experimental | ODM-216 Receives: Drug: ODM-216 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start3 Sep 2026
- Primary completion10 Jan 2028 (estimated)
- Study completion10 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director Clinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805252
- Sponsor's protocol ID
- 3138001
- Other IDs
- 2026-525864-17-00
- Acronym
- BICIDES
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07805252
- Acronym / sponsor ID
- BICIDES / 3138001
- Conditions
- Advanced Solid Tumors Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 10 Jan 2028 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODM-216 | Experimental | Drug: ODM-216ODM-216 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
- Refer to the protocol for the full list of exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODM-216ODM-216 | Drug | ODM-216 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).
Time frame: 12 months
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director Clinical Study Director study director
Orion Corporation, Orion Pharma
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ODM-216 in people with Advanced Solid Tumors Cancer, run by Orion Corporation, Orion Pharma at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Director Clinical Study Director (+358104261, clinicaltrials@orionpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]). (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.