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

NCT05592626 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CP-START-001
• Study Type: interventional
• Target: 365
• Locations: 4 countries
• Sites: 32

Brief 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.

Conditions

Advanced Solid Tumors; Genital Neoplasm, Female; Urogenital Neoplasms; Lung Neoplasm; Neoplasms by Site; Papillomavirus Infection; Epstein-Barr Virus Infections; Carcinoma; Neoplasms; Vulvar Neoplasms; Vulvar Diseases; Abdominal Neoplasm

Keywords

Advanced Solid Tumors; STAR0602; Intravenous; Antineoplastic Agents; T Cell Receptor-targeting; Bifunctional Antibody-Fusion; Specific T Cell Activator; Tumor Mutational Burden (TMB) High; Microsatellite Instability (MSI) High; Virally Associated Malignancies; Checkpoint Inhibitor Resistance; Immunotherapy; Immune Checkpoint Inhibitor Resistance; Head and Neck Cancer; Nasopharyngeal Cancer; Non-small Cell Lung Cancer; Small Cell Lung Cancer; Biliary Cancer; Melanoma; Merkel Cell Carcinoma; Skin Squamous Cell Carcinoma; Skin Basal Cell Carcinoma; Endometrial Cancer; Colorectal Cancer; Small Bowel Cancer; Cervical Cancer; Gastrointestinal Neoplasms; Gastric Cancer; Esophageal Cancer; Bladder Cancer

Outcome Measures

Primary Outcomes (3)

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

  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)

  Up to 3 years

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

  Complete response (CR) and partial response (PR)

  Up to 3 years

Secondary Outcomes (12)

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

Study Arms (2)

Phase 1: Advanced Solid Tumors

EXPERIMENTAL

Dose Escalation; Intervention: Drug: STAR0602

Drug: STAR0602

Phase 2: Advanced Solid Tumors

EXPERIMENTAL

Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602

Drug: STAR0602

Interventions

STAR0602 DRUG

solution, intravenous infusion

Phase 1: Advanced Solid Tumors; Phase 2: Advanced Solid Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• For Phase 1, participants must have one of the following solid tumors:
• High mutational burden (TMB-H)
• Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
• Virally associated tumors
• For Phase 2, participants must have one of the following solid tumors:
• TMB-H
• MSI-H/dMMR
• CRC (both Ras wild type and mutant)
• Virally associated tumors
• Metastatic triple negative breast cancer
• Platinum-resistant epithelial ovarian cancer
• Metastatic castration-resistance prostate cancer
• Primary stage IV or recurrent non-small cell lung cancer
• Immunogenic solid tumors

You may not qualify if:

• 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.
• Major surgery or traumatic injury within 8 weeks before first dose of study drug.
• Unhealed wounds from surgery or injury.
• 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.
• Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
• Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
• Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
• Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.

Sponsors & Collaborators

• Marengo Therapeutics, Inc.: lead

Study Sites (32)

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

RECRUITING

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

AdventHealth Celebration

Celebration, Florida, 34747, United States

RECRUITING

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

The University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

National Institutes of Health

Bethesda, Maryland, 20892, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma Health Sciences, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

UT Health Mays Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

University of Wisconsin- Madison

Madison, Wisconsin, 53792, United States

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Research Institute of McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

RECRUITING

Hopsital Institut Curie

Paris, France, 75248, France

RECRUITING

Oncopole Claudius Regaud IUCT

Toulouse, France, 31100, France

RECRUITING

Institut Bergonié

Bordeaux, 33076, France

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

Institute Gustave Roussy

Villejuif, 94800, France

RECRUITING

Vall d'Hebron Institute of Oncology

Barcelona, Catalonia, 08035, Spain

RECRUITING

Clinica Universidad de Navarra

San Blas-Canillejas, Madrid, 28027, Spain

RECRUITING

Hospital Universitario Quirónsalud Madrid

Madrid, Spain, 28223, Spain

RECRUITING

NEXT Oncology Barcelona, Hospital Quirónsalud Barcelona

Barcelona, 08023, Spain

RECRUITING

START Madrid FJD

Madrid, 28040, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Instituto de Investigacion Sanitaria, INCLIVA

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Genital Neoplasms, Female; Urogenital Neoplasms; Lung Neoplasms; Neoplasms by Site; Papillomavirus Infections; Epstein-Barr Virus Infections; Carcinoma; Neoplasms; Vulvar Neoplasms; Vulvar Diseases; Abdominal Neoplasms; Microsatellite Instability; Head and Neck Neoplasms; Nasopharyngeal Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Biliary Tract Neoplasms; Melanoma; Carcinoma, Merkel Cell; Carcinoma, Basal Cell; Endometrial Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms; Gastrointestinal Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Genomic Instability; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Digestive System Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Neoplasms, Basal Cell; Uterine Neoplasms; Uterine Diseases; Intestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Cervical Diseases; Stomach Diseases; Esophageal Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases

Central Study Contacts

Ke Liu, MD, PhD

CONTACT

+1 (617) 917-4980; kliu@marengotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 24, 2022
• Study Start: January 4, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); ES (7); CA (2); FR (5)