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
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours
CONDITIONS
Official 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 or older
- Histological diagnosis of locally advanced or metastatic solid tumor not treatable with curative intent, including mesothelioma, epithelioid hemangioendothelioma, cholangiocarcinoma, head and neck squamous cell carcinoma, non-small cell lung carcinoma, colorectal cancer, hepatocellular cancer, castration-resistant prostate cancer, meningioma, or other tumors with specific genetic alterations or based on sponsor's scientific data
- Need for systemic cancer treatment and refractory, progressed on, intolerant to, or not candidate for established therapies
- For Part 2: measurable disease by RECIST v1.1 or modified RECIST for malignant pleural mesothelioma
- For Part 2: availability of a fresh or recent tumor tissue sample
- ECOG performance status of 0 or 1
- 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...
- Active malignancy within past 2 years except certain treated skin, bladder, cervical, or breast cancers
- Anti-cancer therapy within 2 weeks before study drug or unresolved toxicity Grade 2 or higher (except certain controlled conditions)
- Definitive radiation therapy within 4 weeks, palliative radiotherapy within 2 weeks, or radiopharmaceuticals within 8 weeks before study drug
- Brain or subdural metastases unless asymptomatic or treated
- Known HIV infection
- Active infection requiring therapy including hepatitis B or C
- Major surgery within 4 weeks, minor surgery within 1 week before study drug
- Immunosuppressive systemic medication within 2 weeks before study drug
- Inability to take oral medication or uncontrolled gastrointestinal conditions affecting drug absorption
- Use of other investigational drugs within 2 weeks or longer depending on drug half-life
- Use of live or live-attenuated vaccines within 28 days before study drug
- Clinically significant ECG abnormalities or risk factors for certain heart arrhythmias
- Significant cardiovascular impairment or recent cardiac events
- Pregnancy or breastfeeding
- Female subjects not using highly effective contraception or abstinent as defined
- Male subjects not vasectomized or whose partners do not meet contraception criteria
- Kidney impairment or certain abnormal laboratory values related to kidney or liver function
- Abnormal coagulation values unless on anticoagulant therapy within therapeutic range
- Low blood counts below specified levels
- Any major illness or condition increasing risk or compromising participation
- Prior treatment with other TEAD inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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