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Monoclonal Antibodies

FT538 + Enoblituzumab for Ovarian & Related Cancers

Phase 1

Waitlist Available

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirements (no limit to the maximum number of prior treatments). Platinum Resistant: may receive FT538 as 2nd line (as 1st salvage therapy).

At least 18 years of age at the time of consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 months

Awards & highlights

Study Summary

This trial tests a drug combo to find the best dose for ovarian, fallopian tube and primary peritoneal cancer patients.

Who is the study for?

This trial is for adults with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Participants must have a certain level of physical fitness (GOG Performance Status 0-2), proper organ function, and no severe heart or lung conditions. They should not be pregnant, breastfeeding, planning pregnancy soon, have active infections uncontrolled by treatment, or known allergies to FT538 components.Check my eligibility

What is being tested?

The study aims to find the highest dose of FT538 that patients can tolerate when given through an IP catheter alone and alongside IV enoblituzumab. Both are potential treatments for cancers of the ovary, fallopian tube, and peritoneum that have come back after previous therapies.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar treatments include reactions at the infusion site (like pain or swelling), fatigue, allergic reactions to medication components (such as albumin in FT538), and potential worsening of underlying health issues.

Eligibility Criteria

Inclusion Criteria

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

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My ovarian, fallopian tube, or peritoneal cancer is resistant to platinum and I can receive FT538 as my second line of treatment.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My heart functions well and I haven't had major heart issues in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 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

Determine Maximum Tolerated Dose (MTD) of FT538

Secondary outcome measures

Adverse Events

Determine progression-free survival (PFS)

Overall Response Rate (ORR)

Other outcome measures

Tumor biopsies (if feasible) at the time of catheter placement and catheter removal for study related analysis

Trial Design

2Treatment groups

Experimental Treatment

Group I: IP FT538 monotherapyExperimental Treatment1 Intervention

Level -1: IP FT538 monotherapy 5 x 10^7 cells/dose Level 1: IP FT538 monotherapy 1 x 10^8 cells/dose Level 2: IP FT538 monotherapy 3 x 10^8 cells/dose Level 3: IP FT538 monotherapy 1 x 10^9 cells/dose Level 4: IP FT538 monotherapy 1.5 x 10^9 cells/dose

Group II: IP FT538 + EnoblituzumabExperimental Treatment2 Interventions

Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enoblituzumab

2021

Completed Phase 1

~180

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,703 Previous Clinical Trials

40,931,717 Total Patients Enrolled

Masonic Cancer Center, University of MinnesotaLead Sponsor

274 Previous Clinical Trials

14,758 Total Patients Enrolled

Media Library

Enoblituzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05708924 — Phase 1

Cancer Research Study Groups: IP FT538 + Enoblituzumab, IP FT538 monotherapy

Cancer Clinical Trial 2023: Enoblituzumab Highlights & Side Effects. Trial Name: NCT05708924 — Phase 1

Enoblituzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708924 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned IP FT538 as a single-medicine treatment?

"Given the limited clinical data supporting IP FT538 monotherapy's efficacy and safety, we gave it a score of 1."

Answered by AI

Is this investigation currently recruiting participants?

"According to clinicaltrials.gov, this trial has stopped recruiting participants and is not accepting new members. Initially posted on January 30th 2023, the study was most recently updated on January 24th 2023. However, 1430 other studies are still open for enrolment today."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

2023. "MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05708924.