A 2-part Phase 1/2 Open-label Trial on ODM-212 (NCT07563738) | Clinical Trial Compass
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
United States229 participantsStarted 2026-03-27
Plain-language summary
An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female participants ≥18 years old.
* Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Life expectancy of \>12 weeks, in the opinion of the investigator.
* Ability to take oral medications and willing to record daily adherence to investigational product.
* Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to receive one of the anti-cancer therapies studied in this trial according to the investigator.
* Arm A: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive treatment with ipilimumab/nivolumab; participants must not have undergone surgical therapy for mesothelioma.
* Arm B: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive treatment with nab-paclitaxel and gemcitabine.
* Arm C: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who have received the available 1st line treatment and who are eligible for a treatment with sotorasib and have not received a KRAS G12C inhibitor as prior treatment.
Part 2:
* Ipilimumab/nivolumab cohort: Participants with histologically or cytologically confirmed diagnosis of ad…
What they're measuring
1
Incidence of Dose Limiting Toxicities and Adverse Events
Timeframe: Through study completion, on average of 2 years