ORM-5029 for HER2-Positive Breast Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Orum Therapeutics USA, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called ORM-5029 in patients with advanced cancers that have the HER2 protein. The drug aims to find and attack these specific cancer cells. ORM-5029 is being tested for its ability to target HER2-positive cancer cells, a strategy previously explored with other drugs.

Eligibility Criteria

This trial is for adults with advanced breast cancer that tests positive for HER2. Participants should have tried standard treatments without success, or be unable to tolerate them. They must have a life expectancy of at least 12 weeks, good heart function, and stable organ and blood functions. Women of childbearing age need a negative pregnancy test and agree to use contraception; men also need to agree to contraception use.

Participant Groups

ORM-5029 is being tested in this Phase 1 trial on people with HER2-positive advanced solid tumors. The study has two parts: first, finding the right dose (Dose Escalation), then seeing how well it works at that dose (Dose Expansion).

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose ExpansionExperimental Treatment1 Intervention

All participants receive ORM-5029 at dose levels with pharmacodynamic activity or efficacy signals (Expansion Cohort A) or at the Expansion Dose Level (EDL) (Expansion Cohorts B and C).

Group II: Part 1 Dose EscalationExperimental Treatment1 Intervention

All participants receive ORM-5029 in escalating dose cohorts in Part 1 Dose Escalation and at the Expansion Dose Level (EDL) in Part 2 Dose Expansion.