A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours

NCT06725758 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 31340012022-503061-29-00U1111-1291-5455
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours

Conditions

Solid Tumours

Keywords

Solid Tumours

Outcome Measures

Primary Outcomes (2)

• Incidence and frequency of treatment emergent adverse events (TEAE)

  A TEAE is defined as any event arising or worsening after the start of treatment administration until 28 days after the last treatment intake.

  From first dose to 1 year after LSLV

• Severity of TEAE

  All AEs (except proteinuria which is to be graded according to urine albumin/creatinine ratio (UACR) category) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  From first dose to 1 year after LSLV

Study Arms (1)

ODM-212

EXPERIMENTAL

ODM-212 5mg and/or 40mg tablets

Drug: ODM-212

Interventions

ODM-212 DRUG

ODM-212 5mg and/or 40mg tablets

ODM-212

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years old
• Subjects must have histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumour of the kind listed below that is not amenable for treatment with curative intent, e.g.:
• Part 1:
• mesothelioma
• epithelioid hemangioendothelioma (EHE)
• cholangiocarcinoma (CCA)
• head and neck squamous cell carcinoma (HNSCC)
• non-small cell lung carcinoma (NSCLC)
• colorectal cancer (CRC)
• hepatocellular cancer (HCC)
• castration-resistant prostate cancer (CRPC)
• meningioma
• any other solid tumours with available local data for loss-of-function genetic alterations (truncating mutations or gene deletion) in neurofibrin 2 (NF2)/large tumour suppressor kinase (LATS1/LATS2), or Yes-associated protein/ Transiptional coactivator with PDZ-binding motif (YAP/TAZ) fusions
• any other solid tumour based on emerging scientific data as per sponsor's decision.
• Part 2: Any solid tumour type harbouring a Hippo pathway alteration and other tumour types potentially responsive to transcriptional enhanced associate domain (TEAD) inhibition based on data from Part 1 or other existing or emerging scientific data.

You may not qualify if:

• Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the subject has completed curative therapy.
• Prior chemotherapy, immunotherapy (tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before study drug administration, or any persistent unresolved toxicity from previous anti-cancer therapies of common terminology criteria for adverse events (CTCAE) Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Especially, care should be exercised to exclude subjects with potential carry-over nephrotoxic effects from previous therapies (e.g., cisplatin). Luteinizing hormone releasing hormone (LHRH) agonists or antagonists are allowed as concomitant treatment.
• Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before study drug administration. Radiopharmaceuticals (strontium, samarium) within less than 8 weeks before study drug administration.
• Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated with local therapy.
• Known human immunodeficiency virus (HIV) infection.
• Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen and hepatitis C virus (HCV) Ribonucleic acid (RNA). Pre-study testing for these pathogens is not required.
• Major surgery within 4 weeks before the first dose of study drug or minor surgery within 1 week (subject must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).
• Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses \>10 mg/day prednisone or equivalent) within 2 weeks before study drug administration.
• Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212.
• Use of other investigational medicinal products within 2 weeks or at least5 half-lives (whichever is longer) before study drug administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the subject, if taking part in the study. For drugs such as investigational monoclonal antibodies with half-lives \>10 days, at least 8 weeks is required. In addition, all visits (apart from survival follow-up) related to the use of another IMP must be completed before dosing with ODM-212 may commence.
• Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of study drug.
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 ms, a prolonged QTc interval (QTcF/B \>470 ms) as demonstrated by 2 out of 3 repeated ECG at screening, performed according to local practice. A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTc interval.
• Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left ventricular ejection fraction (LVEF) \<50%, cardiac arrhythmia requiring medical treatment (including oral anticoagulation) within 6 months prior to the first dose of study drug.
• Female subjects who are breastfeeding or pregnant at screening or baseline.
• A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Royal Marsden Hospital, London, UK

London, SW36JJ, United Kingdom

RECRUITING

Study Officials

• Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Central Study Contacts

Clinical Study Director

CONTACT

+358104261; clinicaltrials@orionpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 10, 2024
• Study Start: October 26, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)