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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Orion Corporation, Orion Pharma
Study ID
NCT06725758
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ODM-212 — DRUG
    ODM-212 5mg and/or 40mg tablets

Study Details

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

Key Dates

Start date
Oct 26, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
315 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ODM-212
    ODM-212 5mg and/or 40mg tablets

Primary Outcome Measure

Incidence and frequency of treatment emergent adverse events (TEAE) [ Time Frame: From first dose to 1 year after LSLV ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067
David Berz, MD
[email protected]
David Berz, MD (PRINCIPAL_INVESTIGATOR)
UC Irvine HealthOrangeCalifornia92868
Farshid Dayyani, MD
[email protected]
Farshid Dayyani, MD (PRINCIPAL_INVESTIGATOR)
Siteman Cancer CenterSt LouisMissouri63110
Ayse Daylan, MD
[email protected]
Ayse Daylan, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Mrinal Gounder, MD
[email protected]
Mrinal Gounder, MD (PRINCIPAL_INVESTIGATOR)
Westchester Medical CenterValhallaNew York10595
Marjorie Zauderer, MD
[email protected]
Marjorie Zauderer, MD (PRINCIPAL_INVESTIGATOR)
Jefferson University HospitalPhiladelphiaPennsylvania19107
Sarah Gordon, MD
[email protected]
Sarah Gordon, MD (PRINCIPAL_INVESTIGATOR)
University of Texas, MD Anderson Cancer CenterHoustonTexas77030
Vinod Ravi, MD
[email protected]
Vinod Ravi, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Alexander Spira, MD
[email protected]
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Valkyrie Clinical Trials· Los Angeles, CAUC Irvine Health· Orange, CASiteman Cancer Center· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYWestchester Medical Center· Valhalla, NYJefferson University Hospital· Philadelphia, PA

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