A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors

Phase 1

Completed

• Conditions: Tumor, Solid
• Interventions: Drug: agenT-797; Drug: Approved ICIs

• Registration Number: NCT05108623
• Lead Sponsor: MiNK Therapeutics

Brief Summary

This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed/refractory (r/r) solid tumors, as well as define the recommended phase II dose in solid tumors. This Phase 1 study will also explore the safety, tolerability, and preliminary clinical activity of agenT-797 in combination with approved immune checkpoint inhibitors (ICIs), including pembrolizumab and nivolumab, in participants with r/r solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-05
• Study Start: 2022-01-28
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Histological or cytological evidence of relapsed or refractory solid tumor malignancy for which no standard therapy is available or standard therapy has failed
• Measurable disease per RECIST 1.1 as assessed by local site Investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Part 2 only, participants must have progressed per Investigator assessment on pembrolizumab or nivolumab, and agree and are able to continue on the inhibitor(s) while on study
• No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the Principal Investigator

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Exclusion Criteria

• Concurrent invasive malignancy
• Brain and/or leptomeningeal metastases that are untreated or require current therapy
• Prior radiotherapy within 2 weeks of start of study treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2: agenT-797 in Combination with approved ICIs	Approved ICIs	Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care
Part 2: agenT-797 in Combination with approved ICIs	agenT-797	Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care
Part 1: Monotherapy with agenT-797	agenT-797	3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Number Of TEAEs By The Dose Of iNKT Cell Therapy	Baseline through 12 months	This will be determined according to the NCI CTCAE v5.0.
Number Of Dose-limiting Toxicities	Baseline through first 14 days after administration
Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy	Baseline through 12 months	This will be determined according to the NCI CTCAE v5.0.
Severity Grade Of AEs By Dose Of iNKT Cell Therapy	Baseline through 12 months	This will be determined according to the NCI CTCAE v5.0.
Number Of Participants With Treatment-emergent Adverse Events (TEAEs)	Baseline through 12 months	This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

Secondary Outcome Measures

Name	Time	Method
Persistence Of agenT-797 In Peripheral Blood Samples	Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0.5, 1, 2, and 4 hours after cell infusion), and on Days 2, 5, 8, 15, 22, and 29; Weeks 6, 8, and 12; and Months 6, 9, and 12	This will be measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry.
Objective Response Rate (ORR)	Up to 12 months	For solid tumors, this will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), Prostate Cancer Working Group 3 (PCWG3) will be used.
Progression-free Survival (PFS)	Up to 12 months	For solid tumors, this will be determined per RECIST 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), PCWG3 will be used.
Incidence Of Donor-specific Antibody	Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months)
Duration Of Response (DOR)	Up to 12 months	For solid tumors, this will be determined per RECIST 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), PCWG3 will be used.
Incidence Of Panel-reactive Antibody	Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months)

Trial Locations

Locations (8)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Norton Cancer Health; 🇺🇸 Louisville, Kentucky, United States

University of Cincinnati Cancer Center; 🇺🇸 Cincinnati, Ohio, United States

LifeSpan - Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States