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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.

Must not have

Currently receiving or likely to require systemic immunosuppressive therapy.

Active autoimmune disease requiring systemic immunosuppressive therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 months

Awards & highlights

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.

Exclusion Criteria

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

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I am on or might need drugs that weaken my immune system.

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I am on medication to suppress my immune system due to an autoimmune disease.

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I have severe asthma and take long-term medication for it.

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I have an infection that isn't getting better despite treatment.

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I have not received a live vaccine in the last 6 weeks.

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I am allergic to albumin (human) or DMSO.

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I have previously been treated with enoblituzumab.

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I haven't had a stroke, epilepsy, or similar brain conditions in the last 2 years.

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 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,368 Total Patients Enrolled

Masonic Cancer Center, University of MinnesotaLead Sponsor

276 Previous Clinical Trials

14,830 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

~21 spots leftby Sep 2026

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