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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05708924
Recruitment Status : Not yet recruiting
First Posted : February 1, 2023
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Description
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Brief Summary:
To determine the maximum tolerated dose (MTD) of FT538 monotherapy when administered via intraperitoneal (IP) catheter and in combination with intravenous (IV) enoblituzumab in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Cancer Solid Tumor Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Drug: FT538 Biological: Enoblituzumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MT2021-27 Intraperitoneal FT538 With Intravenous Enoblituzumab in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Estimated Study Start Date : May 30, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IP FT538 monotherapy
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
 Drug: FT538
FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.
Experimental: IP FT538 + Enoblituzumab
Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab
 Drug: FT538
FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.

Biological: Enoblituzumab
Enoblituzumab 15 mg/kg IV begin on Day -6 and continuing once every 3 weeks beginning on Day 22 until disease progression or unacceptable toxicity - refer to Section 7.2.1 for timing of the enoblituzumab dose on Day 22 if steroid pre-meds are needed due to an infusion reaction with the 1st enoblituzumab dose as there is a 14 day ban on corticosteroid use after the last dose of FT538
Other Names:
  • RES242
  • MGA271


Outcome Measures
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Primary Outcome Measures :
  1. Determine Maximum Tolerated Dose (MTD) of FT538 [ Time Frame: 48 months ]

    The primary objective of the study is to determine the maximum tolerated dose (MTD) of FT538 monotherapy when administered via intraperitoneal (IP) catheter and in combination with intravenous (IV) enoblituzumab in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.

    Monitor the patient for signs of acute infusion related reaction during and after IP infusion. For IV infusion signs of a possible reaction are rigors and chills, rash, urticaria, hypotension, dyspnea, and angioedema.



Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 72 months ]
    Overall response rate is defined as number of patients who have a partial or complete response to therapy divided by the total number of patients who received treatment.

  2. Determine progression-free survival (PFS) [ Time Frame: 72 months ]
    Number of participants experiencing progression free survival at one year follow up

  3. Adverse Events [ Time Frame: 72 months ]
    Number of participants experiencing adverse events with the combination of Enoblituzumab and FT538


Other Outcome Measures:
  1. Tumor biopsies (if feasible) at the time of catheter placement and catheter removal for study related analysis [ Time Frame: 72 months ]
    Tumors will be biopsied to assess tumor microenvironment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • GOG Performance Status 0, 1, or 2 (refer to Appendix I).
  • Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu or enoblituzumab) start
  • Pulmonary Function: Oxygen saturation ≥ 90% on room air; PFTs are performed only if known history or as medically indicated - if done, must have pulmonary function >50% corrected DLCO and FEV1.
  • Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI; no clinically significant cardiovascular disease including any of the following: stroke or myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher (Appendix I).

Exclusion Criteria:

  • Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months.
  • Currently receiving or likely to require systemic immunosuppressive therapy
  • Active autoimmune disease requiring systemic immunosuppressive therapy.
  • History of severe asthma and currently on chronic systemic medications.
  • Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy.
  • Receipt of any biological therapy, chemotherapy, or radiation therapy (except palliative RT), within 2 weeks prior to the first dose of FT538
  • Live vaccine within 6 weeks prior to start of lympho-conditioning.
  • Known allergy to the following FT538 components: albumin (human) or dimethyl sulfoxide (DMSO).
  • Prior enoblituzumab.
  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment. (Refer to Section 5.1.8 regarding history of brain metastases.)
  • Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic viral hepatitis is allowed.
  • Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to patient.
  • Any medical condition or clinical laboratory abnormality that, per investigator judgement, precludes safe participation in and completion of the study or that could affect compliance with protocol conduct or interpretation of results.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05708924


Contacts
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Contact: Melissa Geller 612-626-3111 gelle005@umn.edu

Locations
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United States, Minnesota
Masonic Cancer Center - University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
More Information
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT05708924    
Other Study ID Numbers: 2021LS103
First Posted: February 1, 2023    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Neoplasms, Female
 Urogenital Neoplasms
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases