OMTX705 + Pembrolizumab for Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Oncomatryx Biopharma S.L.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, OMTX705, alone or with pembrolizumab, in patients with advanced cancer who have no other treatment options. The study aims to find the safest dose and see if the combination works better than OMTX705 alone.

Eligibility Criteria

Adults with advanced or metastatic solid tumors without standard treatment options can join this trial. They must have measurable disease, good organ function, and an ECOG performance status of 0-1. Women who can bear children and men with partners who can must use contraception. Exclusions include active infections, certain heart conditions, pregnancy, recent other cancer treatments, uncontrolled brain metastases, and specific medication interactions.

Inclusion Criteria

Serum albumin ≥3.0 g/dL

I am using birth control as required.

My cancer is advanced or has spread and has been confirmed by a biopsy.

See 6 more

Exclusion Criteria

I have brain metastasis that is not under control.

I've had fluid drained from my abdomen or chest 2+ times in the last month.

I have had pneumonitis or lung disease in the past.

See 14 more

Treatment Details

Interventions

OMTX705 (Monoclonal Antibodies)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewOMTX705 is being tested alone and combined with Pembrolizumab to treat advanced cancers in patients lacking other options. This Phase 1 study will gradually increase doses to find safe levels (dose-escalation) before expanding the number of participants at those levels (expansion phase).

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Monotherapy (OMTX705)Experimental Treatment1 Intervention

OMTX705 is administered as single agent.

Group II: Combination (OMTX705 + pembrolizumab)Experimental Treatment2 Interventions

OMTX705 is administered in combination with pembrolizumab.