RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-01-04
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05592626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. For Phase 1, participants must have one of the following solid tumors:
  3. 1. High mutational burden (TMB-H)
  4. 2. Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
  5. 3. Virally associated tumors
  6. 3. For Phase 2, participants must have one of the following solid tumors:
  7. 1. TMB-H
  8. 2. MSI-H/dMMR
  9. 3. CRC (both Ras wild type and mutant)
  10. 4. Virally associated tumors
  11. 5. Metastatic triple negative breast cancer
  12. 6. Platinum-resistant epithelial ovarian cancer
  13. 7. Metastatic castration-resistance prostate cancer
  14. 8. Primary stage IV or recurrent non-small cell lung cancer
  15. 9. Immunogenic solid tumors
  16. 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:
  17. * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent);
  18. * No concurrent leptomeningeal disease or cord compression.
  1. 1. Participants with a history of known autoimmune disease with exceptions of:
  2. * Vitiligo;
  3. * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;
  4. * History of Graves' disease, now euthyroid for \> 4 weeks;
  5. * Hypothyroidism managed by thyroid replacement;
  6. * Alopecia;
  7. * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.
  8. * Adrenal insufficiency well controlled on replacement therapy.
  9. 2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.
  10. 3. Unhealed wounds from surgery or injury.
  11. 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.
  12. 5. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
  13. 6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
  14. 7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
  15. 8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
  16. 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.
  17. 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).
  18. 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.

Contacts and Locations

Study Contact

Ke Liu, MD, PhD
CONTACT
+1 (617) 917-4980
kliu@marengotx.com

Study Locations (Sites)

AdventHealth Celebration
Celebration, Florida, 34747
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
National Institutes of Health
Bethesda, Maryland, 20892
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Marengo Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-04
Study Completion Date2026-10

Study Record Updates

Study Start Date2023-01-04
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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