STAR0602 for Advanced Cancers

(START-001 Trial)

Recruiting at 12 trial locations

Overseen By Ke Liu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Marengo Therapeutics, Inc.

Must not be taking: Immune-suppressive drugs

Disqualifiers: Autoimmune disease, Cardiovascular, Infection, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

365 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called STAR0602 to see if it is safe and effective for treating advanced cancers with specific markers. The drug is given through an IV and aims to find and destroy cancer cells by recognizing these markers. The study will first determine the best dose and then see how well the drug works in patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take more than 10 mg per day of prednisone (a type of steroid) or other immune-suppressive drugs within 7 days before starting the study drug, unless you have had an allergic reaction to iodinated contrast media.

Eligibility Criteria

This trial is for adults with advanced solid tumors that can't be removed or have spread, and standard treatments aren't working. They must not be pregnant, have had recent major surgery, or uncontrolled infections. For Phase 2, they need specific cancer types like high mutational burden cancers or virally associated tumors.

Inclusion Criteria

My cancer has a high number of mutations, is MSI-H/dMMR, or is caused by a virus.

My cancer is advanced, cannot be surgically removed, and standard treatments have failed.

My brain metastases have been treated and I've had no symptoms for over 14 days.

Exclusion Criteria

I have another cancer that has not been in remission for at least a year.

I do not have serious heart, blood vessel, stomach, inflammation, or lung problems.

I haven't taken more than 10 mg of prednisone or any immune-suppressing drugs in the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

STAR0602 is administered intravenously to assess safety/tolerability and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

Variable duration until MTD/RP2D is determined

Phase 2 Dose Expansion

STAR0602 at RP2D is administered to further evaluate safety and assess preliminary clinical activity

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• STAR0602

Trial Overview The study tests STAR0602, a new antibody-fusion molecule given through an IV to target certain antigens in tumors. It's an early-phase trial (1/2) checking safety and how well it works across multiple centers on participants with advanced solid tumors.

Participant Groups

Group I: Phase 2: Advanced Solid Tumors Experimental Treatment 1 Intervention

Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602

Group II: Phase 1: Advanced Solid Tumors Experimental Treatment 1 Intervention

Dose Escalation; Intervention: Drug: STAR0602

Who Is Running the Clinical Trial?

Marengo Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

420+