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Monoclonal Antibodies

Luveltamab Tazevibulin for Ovarian Cancer

Phase 2 & 3

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

High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer

Must not have

Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor

Primary platinum-refractory disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a new drug to treat ovarian cancer in women with FOLR1 gene expression. It will measure safety and effectiveness.

Who is the study for?

This trial is for women aged 18+ with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. Participants must have FOLR1-positive tumors, be somewhat active (ECOG 0-1), and have had 1-3 prior treatments including bevacizumab unless contraindicated. They can't join if they've had severe allergies to monoclonal antibodies, certain serious health conditions, previous organ transplants, CNS involvement, are in another treatment trial or have specific types of ovarian carcinoma.

What is being tested?

The study tests Luveltamab tazevibulin's effectiveness and safety on women with certain types of ovarian cancer expressing FOLR1. It's a Phase 2 trial where participants also receive Pegfilgrastim to help reduce infection risk from low white blood cell counts.

What are the potential side effects?

Possible side effects include allergic reactions related to the immune system targeting normal cells by mistake (infusion reactions), fatigue due to anemia or other factors affecting energy levels; digestive issues like nausea or diarrhea; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can carry out all my usual activities without help.

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I have high grade serous cancer in my ovary, fallopian tube, or peritoneum.

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My ovarian cancer has returned after platinum treatment, and I've had 1-3 prior treatments.

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I have received bevacizumab for ovarian cancer or cannot take it due to health reasons.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific targeted therapy for cancer.

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My cancer did not respond to initial platinum-based chemotherapy.

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I do not have severe eye, lung, heart, brain disorders, or other serious health issues.

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My cancer has spread to my brain or spinal cord.

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My ovarian cancer is low grade and not the most common type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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)

Progression Free Survival (PFS)

Secondary study objectives

Duration of Response (DOR)

Incidence and severity of adverse events [Safety and tolerability]

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Luveltamab tazevibulin dose Cohort BExperimental Treatment1 Intervention

4.3 mg/kg q3w

Group II: Luveltamab tazevibulin dose Cohort AExperimental Treatment2 Interventions

5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards

Group III: Part 2: IC ChemotherapyActive Control4 Interventions

* Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 q4w or 1000mg/m2 on Days 1 and 8 q3w * Paclitaxel 80 mg/m2 on Days 1, 8, and 15 q4w * Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 q4w * Topotecan 4.0 mg/m2on Day 1, 8, and 15 q4w or 1.25 mg/m2 on Days 1 - 5 q3w

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegfilgrastim

2013

Completed Phase 3

~4440

0 / 10Eligibility criteria met