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A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

ConditionsAdvanced Solid TumorsGenital Neoplasm, FemaleUrogenital NeoplasmsLung NeoplasmNeoplasms by SitePapillomavirus InfectionEpstein-Barr Virus InfectionsCarcinomaNeoplasmsVulvar NeoplasmsVulvar DiseasesAbdominal NeoplasmNSCLC (Non-small Cell Lung Cancer)Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarengo Therapeutics, Inc.

About this trial

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Participants should not have received more than three regimens of prior therapies for their advanced or metastatic diseases. For Phase 2 Cohorts 8 and 10 (see below), participants should not have received more than one line of prior therapy.

High mutational burden (TMB-H)

Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)

Virally associated tumors

Disqualifiers

Vitiligo;

Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;

History of Graves' disease, now euthyroid for > 4 weeks;

Hypothyroidism managed by thyroid replacement;

Trial design

Design model

Sequential

Treatments tested in this trial

  • STAR0602

    Drug

    solution, intravenous infusion

  • Irinotecan (Camptosar)

    Combination product

    solution, intravenous infusion

  • Docetaxel (Taxotere)

    Combination product

    solution, intravenous infusion

Treatment groups

366 Participants
are divided into 2 treatment groups
Group A: Phase 1: Advanced Solid TumorsExperimental treatment 1 intervention
Group B: Phase 2: Advanced Solid TumorsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1

Time frame
Cycle 1 (Cycle length= 28 days)
2

Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
Up to 3 years
3

Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)

Complete response (CR) and partial response (PR)

Time frame
Up to 3 years

Secondary outcomes

1

Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with ORR

Time frame
Up to 3 years
2

Phase 1 and 2 (Dose Escalation and Expansion): Duration of Responses (DOR)

Time frame
Up to 3 years
3

Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with Disease Control (CR, PR, and Stable Disease)

Time frame
Up to 3 years
4

Phase 2 (Dose Expansion): Progression Free Survival (PFS)

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marengo Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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