A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors (START-001)

August 6, 2026 updated by: Marengo Therapeutics, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • Lillian Siu, MD
        • Contact:
          • Lillian Siu, MD
          • Phone Number: 416-946-2911
  • France
      • Villejuif, France, 94800
        • Recruiting
        • Institute Gustave Roussy
        • Principal Investigator:
          • Aurelien Marabelle, MD
        • Contact:
          • Romain Di-Vincenzo
          • Phone Number: +33 1 42 11 58 31
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • START Madrid FJD
        • Contact:
          • Manuel Pedregal
          • Phone Number: Ext: 2805 +34 91 550 48 00
        • Principal Investigator:
          • Manuel Pedregal, MD
      • Valencia, Spain, 46010
        • Recruiting
        • Instituto de Investigacion Sanitaria, INCLIVA
        • Contact:
        • Principal Investigator:
          • Susana Roselló, MD
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology
        • Principal Investigator:
          • Elena Garralda, MD
        • Contact:
          • Gemma Mur
          • Phone Number: 8974 (+34) 932 54 34 50
    • Spain
      • Madrid, Spain, Spain, 28223
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
        • Principal Investigator:
          • Valentina Boni, MD
        • Contact:
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • UC Davis Comprehensive Cancer Center
    • Florida
      • Celebration, Florida, United States, 34747
        • Recruiting
        • AdventHealth Celebration
        • Principal Investigator:
          • Guru Sonpavde, MD
        • Contact:
          • Guru Sonpavde, MD
          • Phone Number: 407 303 2024
      • Miami, Florida, United States, 33136
        • Active, not recruiting
        • University of Miami Sylvester Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Weijing Sun, MD
    • Maryland
      • Bethesda, Maryland, United States, 20892
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Principal Investigator:
          • Ryan Sullivan, MD
        • Contact:
          • Ryan Sullivan, MD
          • Phone Number: (617) 643-3614
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
          • Victoria LaBush
          • Phone Number: 313-576-8411
        • Principal Investigator:
          • Wasif Saif, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Asrar Alahmadi, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)
        • Principal Investigator:
          • Meredith Pelster, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas, MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Pia Morelli, MD, PhD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health Mays Cancer Center
        • Contact:
        • Principal Investigator:
          • Sukeshi Patel Arora, MD
    • Washington
      • Seattle, Washington, United States, 98109
        • Active, not recruiting
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin- Madison
        • Contact:
        • Principal Investigator:
          • Vincent Ma, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. 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.

  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
    4. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor's approval.

  3. For Phase 2, participants must have one of the following solid tumors:

    1. TMB-H (not enrolling)
    2. MSI-H/dMMR (not enrolling)
    3. CRC (both Ras wild type and mutant) (not enrolling)
    4. NSCLC (recurrent or Primary Stage 4)
    5. CRC with pMMR/MSS (without TMB-H requirement)

    (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.

  5. Subjects who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti CTLA 4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the CPI) to be eligible for enrollment.

    • Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy.
    • Subjects who have had previous CPI-related Grade 3 to 4 pneumonitis, peri/myocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy will need Sponsor approval.

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. Prior therapy within the following timeframe before planned infusion of STAR0602 as follows:

    • Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to a previously administered agent;
    • Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to agents administered more than 4 weeks earlier. Note: Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
  6. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
  7. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
  8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
  9. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
  10. 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.
  11. 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).
  12. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.
  13. Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1: Advanced Solid Tumors
Dose Escalation; Intervention: Drug: STAR0602, Invikafusp alfa
Drug: STAR0602
solution, intravenous infusion
Other Names:
  • Invikafusp alfa
Experimental: Phase 2: Advanced Solid Tumors
Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602, Invikafusp alfa
Drug: STAR0602
solution, intravenous infusion
Other Names:
  • Invikafusp alfa
Combination product: Irinotecan (Camptosar)
solution, intravenous infusion
Other Names:
  • Camptosar
Combination product: Docetaxel (Taxotere)
solution, intravenous infusion
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1
Time Frame: Cycle 1 (Cycle length= 28 days)
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
Up to 3 years
Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)
Time Frame: Up to 3 years
Complete response (CR) and partial response (PR)
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with ORR
Time Frame: Up to 3 years
Up to 3 years
Phase 1 and 2 (Dose Escalation and Expansion): Duration of Responses (DOR)
Time Frame: Up to 3 years
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
Up to 3 years
Phase 2 (Dose Expansion): Progression Free Survival (PFS)
Time Frame: Up to 3 years
Up to 3 years
Phase 2 (Dose Expansion): Overall Survival (OS)
Time Frame: Up to 3 years
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)
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)
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)
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)
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)
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)
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)
Dose Escalation and Expansion: Day 1 of predetermined cycles up to 3 years (Cycle length= 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

January 4, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-START-001
  • 2023-505334-10-01 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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