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

MiNK Therapeutics

Status and phase: Completed; Phase 1

Conditions: Tumor, Solid

Treatments: Drug: agenT-797; Drug: Approved ICIs

Study type: Interventional

Funder types: Industry

Identifiers

NCT05108623

2021-1306

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Part 1: Monotherapy with agenT-797

Experimental group

Description:

3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.

Treatment:

Drug: agenT-797

Part 2: agenT-797 in Combination with approved ICIs

Experimental group

Description:

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

Treatment:

Drug: agenT-797

Drug: Approved ICIs