ODM-212 for Solid Tumors

(TEADES Trial)

Recruiting at 19 trial locations

Overseen By Clinical Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Orion Corporation, Orion Pharma

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Active infection, Cardiovascular impairment, others

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

Compensation: Varies

Number of Visits: Unknown

315 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ODM-212, a potential drug for individuals with certain advanced solid tumors that current treatments cannot cure. The study aims to determine the optimal dose and evaluate ODM-212's effectiveness in combating these cancers. Participants must have a type of solid tumor specified in the trial details and require systemic treatment after other therapies have failed or are unsuitable. As a Phase 1 trial, this research focuses on understanding ODM-212's effects in humans, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had chemotherapy, immunotherapy, or other anti-cancer treatments within 2 weeks before starting the study drug. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ODM-212 is likely to be safe for humans?

Research has shown that ODM-212 has promising safety results from early lab studies, effectively targeting specific proteins linked to tumor growth. Initial findings indicate that ODM-212 possesses favorable safety features.

In current studies testing ODM-212 in people, the main goal is to assess its safety and tolerability. Researchers monitor participants' reactions to the drug and any side effects. They carefully increase the dose to determine the optimal amount that is both effective and safe.

So far, data suggests that ODM-212 is well-tolerated. However, as it remains in early trials, more detailed safety information will emerge as research progresses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ODM-212 is unique because it offers a new approach in targeting solid tumors. Unlike traditional treatments like chemotherapy, which attack both cancerous and healthy cells, ODM-212 specifically aims to block certain proteins that are crucial for tumor growth, potentially reducing side effects and increasing effectiveness. Researchers are excited about its potential to be taken as an oral tablet at different dosages, providing flexibility and convenience compared to intravenous therapies.

What evidence suggests that ODM-212 might be an effective treatment for solid tumors?

Research has shown that ODM-212 might slow or stop cancer growth by blocking certain proteins called TEADs, which contribute to tumor development. Early lab studies demonstrated that tumors absorb ODM-212 well and that it continues to work effectively, showing strong anti-tumor activity. The drug may also prevent cancer cells from becoming resistant to other treatments. This trial will evaluate ODM-212 in participants with advanced solid tumors to confirm these early findings. ^{2 3 4 6 7}

Who Is on the Research Team?

Clinical Study Director

Principal Investigator

Orion Corporation, Orion Pharma

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have not responded to standard treatments or who can't receive them. Participants must be in good physical condition, able to take oral medication, and not pregnant or breastfeeding. People with certain heart issues, active infections, recent cancer therapies, brain metastases needing treatment, or severe organ problems cannot join.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with advanced or metastatic solid cancer.

Life expectancy of >12 weeks

Exclusion Criteria

I have not had major radiation in the last 4 weeks or palliative radiation in the last 2 weeks.

I cannot take medicines by mouth or have serious digestive problems.

I have been treated with TEAD inhibitors before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ODM-212 to determine the maximum tolerated dose

8-12 weeks

Dose Expansion

Participants receive the determined dose of ODM-212 to further evaluate safety and efficacy

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ODM-212

Trial Overview

The study is testing a new drug called ODM-212 in people with advanced solid tumors. It has two parts: first finding the best dose (dose escalation), then expanding to more patients at that dose (dose expansion). All participants will receive ODM-212 by mouth.

How Is the Trial Designed?

Group I: ODM-212 Experimental Treatment 1 Intervention

ODM-212 5mg and/or 40mg tablets

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

Citations

1.

mskcc.org

mskcc.org/cancer-care/clinical-trials/25-275

A Phase 1-2 Study of ODM-212 in People With Advanced ...

By blocking TEADs, ODM-212 may help slow or stop the growth of your cancer. It is taken orally (by mouth). Who Can Join. To join this study, there are a few ...

2.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(25)05966-6/pdf

180P Preclinical evaluation of the novel TEAD inhibitor ...

Conclusions: Radiolabeled 177Lu-D7ND demonstrated high tumor uptake, prolonged retention, and favorable antitumor efficacy in preclinical models, indicating its ...

3.

orionpharma.com

orionpharma.com/newsroom/all-news/releases/press-releases/2026/orion-pharma-initiates-teadco-phase-1b2-basket-trial-evaluating-odm-212-in-combination-with-standard-of-care-treatments-in-patients-with-select-advanced-solid-tumours/

Orion Pharma initiates TEADCO Phase 1b/2 basket trial ...

ODM-212 has the potential to both exert direct anti-tumour activity and prevent emergence of treatment resistance to standard of care ...

4.

isrctn.com

isrctn.com/ISRCTN99739590

First-in-human study evaluating the effect of various doses ...

The primary purpose of this study is to look at the safety of ODM-212 when given to participants who have locally advanced primary or recurrent cancer, or ...

5.

ctv.veeva.com

ctv.veeva.com/study/two-part-first-in-human-study-on-odm-212-in-subjects-with-selected-advanced-solid-tumours

A Phase 1/2, First-in-Human Study On ODM-212 In Subjects ...

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

6.

clinicaltrials.eu

clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-odm-212-for-patients-with-advanced-solid-tumors/

Study on the Safety and Tolerability of ODM-212 for ...

This clinical trial is focused on studying the effects of a new medication called ODM-212 in individuals with certain types of advanced solid tumors.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07563738

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

Also called a data safety and monitoring board ... 212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours.