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Clinical Trial ● Currently Recruiting Phase I NCT07563738

A 2-part Phase 1/2 Open-label Trial on ODM-212

A 2-part Phase 1/2 Open-label Trial on ODM-212 — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT07563738.

📅 22 Oct 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT07563738
Sponsor
Orion Corporation, Orion Pharma
Start
2026-03-27
ClinicaliQ Trial Snapshot
  • A 2-part Phase 1/2 Open-label Trial on ODM-212 — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT07563738.
  • What is being tested: ODM-212 is a novel therapeutic agent being evaluated through a structured phase 1/2 trial design, progressing from initial dose escalation to determine safety and tolerability, followed by dose expansion to optimise efficacy and establish recommended treatment protocols.
  • Patient eligibility overview: The trial employs a multi-cohort, open-label design across multiple sites, allowing flexible recruitment of patient populations; specific eligibility criteria would determine whether patients have specific disease types, disease severity thresholds, or prior treatment requirements.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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

Eligibility Snapshot
  • : * 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…

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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