Advanced Solid Tumors Cancer
Conditions
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
Interventions
DRUGODM-216
ODM-216
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]). | 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. |
Countries
Spain
Contacts
CONTACTClinical Study Director Clinical Study Director
STUDY_DIRECTORStudy Director Clinical Study Director
Orion Corporation, Orion Pharma
Outcome results
None listed