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PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing ODM-212 for Mesothelioma

An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)

Official registry: https://clinicaltrials.gov/study/NCT07563738 · Orion Corporation, Orion Pharma · enrollment listed as 229

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ODM-212, Ipilimumab and nivolumab, or Gemcitabine and nab-paclitaxel. The registry lists allocation as randomized. An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)

They plan to enroll about 229 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours

Interventions: ODM-212, Ipilimumab and nivolumab, Gemcitabine and nab-paclitaxel, sotorasib

Primary outcome (registry wording): Incidence of Dose Limiting Toxicities and Adverse Events

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Clinical Study Director

+358104261

clinicaltrials@orionpharma.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

23 listed

+ 18 sites outside the US on the same record

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NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT07563738 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07563738?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07563738?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary