Actively Recruiting
A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours
Led by Orion Corporation, Orion Pharma · Updated on 2026-05-08
315
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ODM-212, a drug being studied in a first-in-human, multi-site, open-label Phase 1/2 clinical trial involving adults with selected advanced solid tumors that cannot be treated with curative intent. The study aims to assess the safety and side effects of ODM-212 in patients who have cancers such as mesothelioma, lung carcinoma, colorectal cancer, and others with specific genetic alterations. This research is sponsored by Orion Corporation, Orion Pharma. Participants receive ODM-212 tablets at doses of 5mg and/or 40mg. The study has two parts: an initial dose escalation phase to find a safe dose, followed by a dose expansion phase that includes patients with solid tumors harboring specific genetic pathway alterations. Treatments are given orally, and dosing details are adjusted based on patient response and safety observations. During the study, participants will be monitored from the first dose until one year after the last study visit to track treatment-emergent adverse events and their severity. Regular assessments include physical exams, laboratory tests, and performance status evaluations. Participants must comply with the protocol and provide informed consent. The total study duration varies based on treatment and follow-up schedules.
CONDITIONS
Brief Title
A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 18 years old or older
- Histological diagnosis of locally advanced or metastatic solid tumor not treatable with curative intent, including specific tumor types listed
- Need for systemic treatment and have progressed on or are intolerant to established therapies
- For part 2: measurable disease by RECIST v.1.1 or modified RECIST for malignant pleural mesothelioma
- For part 2: availability of a fresh or recent tumor tissue sample
- Performance status 0-1 on ECOG scale
- Life expectancy greater than 12 weeks
- Willing and able to comply with study protocol
- Provide written informed consent prior to screening
You will not qualify if you...
- Other active malignancy within 2 years except certain skin, bladder, cervical, or breast cancers with completed therapy
- Recent chemotherapy, immunotherapy, or anti-cancer therapy within specified timeframes or unresolved toxicity of grade 2 or higher
- Recent definitive or palliative radiation therapy within specified timeframes
- Brain or subdural metastases unless asymptomatic or adequately treated
- Known HIV infection
- Active infection requiring therapy or positive Hepatitis B or C tests
- Recent major or minor surgery with ongoing toxicity
- Use of immunosuppressive doses of systemic medications within 2 weeks
- Inability to take oral medication or uncontrolled gastrointestinal conditions
- Use of other investigational drugs within specified timeframes
- Use of live or live-attenuated vaccines within 28 days
- Significant ECG abnormalities or risk factors for heart rhythm issues
- Significant cardiovascular impairment or recent cardiac events
- Female subjects who are pregnant or breastfeeding
- Non-compliance with contraception requirements for females of childbearing potential and males without successful vasectomy
- Kidney or liver impairment based on laboratory tests
- Abnormal coagulation values unless on stable anticoagulant therapy
- Low blood counts below specified thresholds
- Any other major illness or medical condition increasing risk or compromising participation
- History of treatment with other TEAD inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first dose until treatment discontinuation or disease progression
Participants receive ODM-212 tablets at specified doses as part of the study treatment.
Visits occur regularly during treatment as scheduled by the study team
Duration - Up to 1 year after last study treatment
Participants are monitored for safety and adverse events for up to 1 year after the last study treatment.
Periodic follow-up visits for safety assessments
Trial Site Locations
Total: 20 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
UC Irvine Health
Orange, California, United States, 92868
Actively Recruiting
3
Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
6
Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Helsinki university Hospital
Helsinki, Finland
Actively Recruiting
10
Oulu University Hospital
Oulu, Finland
Actively Recruiting
11
Turku University Hospital
Turku, Finland
Actively Recruiting
12
Institut Bergonie
Bordeaux, France
Actively Recruiting
13
Centre Oscar Lambret
Lille, France
Actively Recruiting
14
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
15
Hospital 12 de Octubre
Madrid, Spain
Actively Recruiting
16
Hospital Virgen De La Macarena
Seville, Spain
Actively Recruiting
17
Istituto Oncologico, Ospedale Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
18
Leicester Royal Infirmary
Leicester, United Kingdom
Actively Recruiting
19
Royal Marsden Hospital, London, UK
London, United Kingdom, SW36JJ
Actively Recruiting
20
Weston Park Hospital
Sheffield, United Kingdom
Actively Recruiting
Research Team
C
Clinical Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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