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Monoclonal Antibodies
Luveltamab Tazevibulin for Lung Cancer
Phase 2
Recruiting
Research Sponsored by Sutro Biopharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0 to 1
Positive FOLR1 expression per central testing
Must not have
Previous solid organ transplantation
Prior treatment with a FOLR1-targeting ADCs or with ADCs that contain a tubulin inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called STRO-002 in patients with advanced lung cancer that has not responded to previous treatments. The drug targets a specific protein called FOLR1.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include allergic reactions similar to those from monoclonal antibody therapies or fusion protein treatments. Since the drug targets cells that express FOLR1 and contains a tubulin inhibitor, there might be risks related to these mechanisms as well.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer tests positive for FOLR1.
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My lung cancer is advanced and cannot be removed by surgery.
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I am 18 years old or older.
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I've had 2-4 treatments for advanced lung cancer.
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My cancer has worsened despite my last cancer treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a solid organ transplant.
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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.
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I have brain metastases that haven't been treated.
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I am on immunosuppressive therapy, except for treated brain metastases.
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I do not have severe eye, lung, heart, brain disorders, or other serious health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
ADC concentration
Cytotoxic warhead concentration
Duration of Response (DOR) per Investigator's assessment.
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Luveltamab tazevibulinExperimental Treatment1 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.
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Who is running the clinical trial?
Sutro Biopharma, Inc.Lead Sponsor
6 Previous Clinical Trials
1,020 Total Patients Enrolled