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Monoclonal Antibodies

Luveltamab Tazevibulin for Ovarian Cancer

Q: How many venues are currently providing this research trial?

<p>USF Research &#x26; Innovation, Optimum Clinical Research Group and NYU Langone Health are among the 13 clinical sites enrolling participants in this experiment. The other 10 locations span across different states in America.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Progression Free Survival (PFS)

Secondary outcome measures

Duration of Response (DOR)

Incidence and severity of adverse events [Safety and tolerability]

Overall Survival (OS)

+1 more

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

~4410

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK

42 Previous Clinical Trials

16,141 Total Patients Enrolled

7 Trials studying Ovarian Cancer

2,679 Patients Enrolled for Ovarian Cancer

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER

36 Previous Clinical Trials

16,639 Total Patients Enrolled

10 Trials studying Ovarian Cancer

4,791 Patients Enrolled for Ovarian Cancer

Asia-Pacific Gynecologic Oncology Trials Group (APGOT)UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects have been reported with Luveltamab tazevibulin dose cohort A?

"The safety of Part 1: Luveltamab tazevibulin dose cohort A was rated a 2 because, while there is pre-existing evidence for its security, efficacy data has yet to be established."

Answered by AI

How many participants are currently being admitted to this experiment?

"The trial requires 140 conforming individuals at two sites: USF Research & Innovation in Tampa, Florida and Optimum Clinical Research Group in Albuquerque, New mexico."

Answered by AI

Is this investigation presently open to participants?

"Indeed, information from clinicaltrials.gov states that this trial is actively seeking appropriate participants. This study was first advertised on July 12th 2023 and its details were last updated October 10th of the same year. 140 individuals need to be recruited across 10 medical centres for it to commence."

Answered by AI

How many venues are currently providing this research trial?

"USF Research & Innovation, Optimum Clinical Research Group and NYU Langone Health are among the 13 clinical sites enrolling participants in this experiment. The other 10 locations span across different states in America."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

2023. "REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05870748.

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