ODM-212 for Pancreatic Cancer

(TEADCO Trial)

Recruiting at 1 trial location

Overseen By Clinical Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Orion Corporation, Orion Pharma

Must be taking: Ipilimumab, Nivolumab, Nab-paclitaxel, Gemcitabine

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Active infection, Brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

229 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I am fully active or have only minor physical limitations.

* Life expectancy of \>12 weeks, in the opinion of the investigator.

I can take pills by mouth and will track my daily medication use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of ODM-212 in combination with anti-cancer therapy to evaluate safety and tolerability

Variable duration

Dose Expansion/Optimisation

Participants receive optimized doses of ODM-212 in combination with anti-cancer therapy to further evaluate efficacy

Variable duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ODM-212

How Is the Trial Designed?

Group I: ODM-212 with sotorasib in NSCLC Experimental Treatment 2 Interventions

Group II: ODM-212 with ipilimumab/nivolumab in mesothelioma Experimental Treatment 2 Interventions

Group III: ODM-212 with gemcitabine and nab-paclitaxel in PDAC Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Orion Corporation, Orion Pharma

Lead Sponsor

Trials

140

Recruited

45,200+

Liisa Hurme

Orion Corporation, Orion Pharma

Chief Executive Officer since 2022

PhD in Biochemistry, University of Helsinki

Hilpi Rautelin

Orion Corporation, Orion Pharma

Chief Medical Officer since 2023

MD, University of Turku