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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

NCT ID: NCT05592626Sponsor: Marengo Therapeutics, Inc.Last updated: 2025-07-09

Summary

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 administered intravenously in participants with advanced solid tumors that are antigen-rich.

Detailed description

This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).

Arms & interventions

  • DrugSTAR0602

    solution, intravenous infusion

Outcome measures

Primary

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

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

  • 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

  • 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

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

  • 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

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

    Time frame: Up to 3 years

  • Phase 2 (Dose Expansion): Overall Survival (OS)

    Time frame: Up to 3 years

  • Phase 1 and 2 (Dose Escalation and Expansion): Maximum Observed Plasma Concentration (Cmax) for STAR0602

    Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)

  • Phase 1 and 2 (Dose Escalation and Expansion): Time (Tmax) to Reach the Maximum Plasma Concentration (Cmax) for STAR0602

    Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)

  • Phase 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration (AUC) Versus Time Curve for STAR0602

    Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)

  • Phase 1 and 2 (Dose Escalation and Expansion): Terminal Elimination Half-life (t1/2) for STAR0602

    Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)

  • Phase 1 and 2 (Dose Escalation and Expansion): Apparent Total Body Clearance (CL) for STAR0602

    Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)

  • Phase 1 and 2 (Dose Escalation and Expansion): Apparent Volume of Distribution (Vd) for STAR0602

    Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)

  • Phase 1 and 2 (Dose Escalation and Expansion): Anti-drug Antibody (ADA) formation

    Time frame: Dose Escalation and Expansion: Day 1 of predetermined cycles up to 3 years (Cycle length= 28 days)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. 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. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases. 2. For Phase 1, participants must have one of the following solid tumors: 1. High mutational burden (TMB-H) 2. Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR) 3. Virally associated tumors 3. For Phase 2, participants must have one of the following solid tumors: 1. TMB-H 2. MSI-H/dMMR 3. CRC (both Ras wild type and mutant) 4. Virally associated tumors 5. Metastatic triple negative breast cancer 6. Platinum-resistant epithelial ovarian cancer 7. Metastatic castration-resistance prostate cancer 8. Primary stage IV or recurrent non-small cell lung cancer 9. Immunogenic solid tumors (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.) 4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment: * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent); * No concurrent leptomeningeal disease or cord compression. Exclusion Criteria: 1. Participants with a history of known autoimmune disease with exceptions of: * 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; * Alopecia; * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs. * Adrenal insufficiency well controlled on replacement therapy. 2. Major surgery or traumatic injury within 8 weeks before first dose of study drug. 3. Unhealed wounds from surgery or injury. 4. Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed. 5. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises 6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. 7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. 8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease. 9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas. 10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation). 11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.

Study locations (18)

Loma Linda University Cancer Center

Loma Linda, California, 92354

Recruiting
John Shin, MD · Contact
John Shin, MD · Principal Investigator

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817

Recruiting
Kenya Gomez · Contact
Tianhong Li, MD · Principal Investigator

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

Recruiting
Julia Etchart · Contact
Jason Henry, MD · Principal Investigator

AdventHealth Celebration

Celebration, Florida, 34747

Recruiting
Guru Sonpavde, MD · Contact
Guru Sonpavde, MD · Principal Investigator

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting
Marijo Billusic, MD · Contact
Marijo Billusic, MD · Principal Investigator

The University of Kansas Cancer Center

Kansas City, Kansas, 66160

Recruiting
Weijing Sun, MD · Contact
Weijing Sun, MD · Principal Investigator

National Institutes of Health

Bethesda, Maryland, 20892

Recruiting
Victoria Jeffers · Contact
James Gulley, MD, PhD · Principal Investigator

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Recruiting
Ryan Sullivan, MD · Contact
Ryan Sullivan, MD · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Joanne Charles · Contact
Ann Silk, MD · Principal Investigator

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting
Victoria LaBush · Contact
Wasif Saif, MD · Principal Investigator

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

Recruiting
Luisa Belfoiore · Contact
Gopa Iyer, MD · Principal Investigator

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Kai He, MD · Contact
Kai He, MD · Principal Investigator

University of Oklahoma Health Sciences, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Recruiting
Amanda Anundson · Contact
Abdul R Naqash, MD · Principal Investigator

Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)

Nashville, Tennessee, 37203

Recruiting
Ethan Trull · Contact
Meredith Pelster, MD · Principal Investigator

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Ming Sun · Contact
Stephane Champiat, MD · Principal Investigator

UT Health Mays Cancer Center

San Antonio, Texas, 78229

Recruiting
Sheniell Granato · Contact
Sukeshi Patel Arora, MD · Principal Investigator

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Ariana Dumenigo Jimenez · Contact
Joe Lograsso · Contact
Diane Tseng, MD · Principal Investigator

University of Wisconsin- Madison

Madison, Wisconsin, 53792

Recruiting
Vincent Ma, MD · Contact
Vincent Ma, MD · Principal Investigator
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors | Cancerify