Luveltamab Tazevibulin for Lung Cancer

Recruiting at 3 trial locations

Overseen By Jennifer Oliver, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sutro Biopharma, Inc.

Must not be taking: Immunosuppressants, Monoclonal antibodies

Disqualifiers: CNS metastases, COPD, Cardiac disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: up to 24 months

43 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

Adults with advanced or metastatic non-small cell lung cancer who've had at least 2 but no more than 4 prior treatments can join. They must have a certain type of tumor marker (FOLR1), measurable disease, good performance status, and organ function. Excluded are those with previous transplants, other ongoing trials, specific past treatments for FOLR1, untreated brain metastases, severe allergies to monoclonal antibodies or immunosuppressive therapy.

Inclusion Criteria

At least 1 measurable target lesion per RECIST 1.1

I am fully active or can carry out light work.

My organs are working well.

Exclusion Criteria

I have had a solid organ transplant.

Concurrent participation in another therapeutic treatment trial

I have been treated with a specific type of cancer drug targeting FOLR1 or drugs that contain a substance to stop cancer cells from growing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive luveltamab tazevibulin intravenously every 3 weeks until disease progression, intolerable toxicity, elective withdrawal, or study termination

up to 24 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Luveltamab Tazevibulin

Trial Overview The trial is testing Luveltamab tazevibulin in patients who have previously treated non-small cell lung cancer expressing FOLR1. It's a Phase 2 study which means they're looking at how effective this treatment is and gathering more information on its safety.

Participant Groups

Group I: Luveltamab tazevibulin Experimental Treatment 1 Intervention

4.3 mg/kg q3w Eligible subjects with stable disease (SD) may escalate to 5.2 mg/kg q3w after Cycle 4, with Sponsor approval.

Who Is Running the Clinical Trial?

Sutro Biopharma, Inc.

Lead Sponsor

Trials

7

Recruited

1,100+