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Advanced Solid TumorsPhase 1/2START-001NCT05592626

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

A Phase 1/2 study testing STAR0602, Irinotecan (Camptosar) and Docetaxel (Taxotere) in people with Advanced Solid Tumors and Genital Neoplasm, Female, run by Marengo Therapeutics, Inc. at 19 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
STAR0602, Irinotecan (Camptosar) and Docetaxel (Taxotere)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
19 sitesin 4 countries
Study dates
4 Jan 2023to Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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
  • 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.
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  • For Phase 2, participants must have one of the following solid tumors:
  • TMB-H (not enrolling)
  • MSI-H/dMMR (not enrolling)
  • CRC (both Ras wild type and mutant) (not enrolling)
  • NSCLC (recurrent or Primary Stage 4)
  • 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.)
  • 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.
  • 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.

Who cannot join

  • 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;
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  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.
  • Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.

Trial locations and contacts

19 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Ke Liu, MD, PhD contact

+1 (617) 917-4980

kliu@marengotx.com

19 sites in 4 countries

United States13 sites, 10 recruiting

  • National Institutes of Health

    Bethesda, Maryland, 20892

    Melissa Walker, walkerme@mail.nih.gov

    Stephanie Hicks, stephanie.hicks2@nih.gov

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Ryan Sullivan, MD, (617) 643-3614

    Ryan Sullivan, MD

    Recruiting

  • AdventHealth Celebration

    Celebration, Florida, 34747

    Guru Sonpavde, MD, 407 303 2024

    Guru Sonpavde, MD

    Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Asrar Alahmadi, MD, Asrar.Alahmadi@osumc.edu

    Asrar Alahmadi, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Victoria LaBush, 313-576-8411

    Wasif Saif, MD

    Recruiting

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

    Pia Morelli, MD, PhD, MPMorelli@mdanderson.org

    Pia Morelli, MD, PhD

    Recruiting

  • The University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Weijing Sun, MD, wsun2@kumc.edu

    Weijing Sun, MD

    Recruiting

  • University of Wisconsin- Madison

    Madison, Wisconsin, 53792

    Vincent Ma, MD, vtma@medicine.wisc.edu

    Vincent Ma, MD

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Active, not recruiting

  • Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)

    Nashville, Tennessee, 37203

    Abi Warnke, Abi.Warnke@scri.com

    Meredith Pelster, MD

    Recruiting

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Active, not recruiting

  • UT Health Mays Cancer Center

    San Antonio, Texas, 78229

    Sheniell Granato, 210-450-1950, granatos@uthscsa.edu

    Sukeshi Patel Arora, MD

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Active, not recruiting

Other trials in United States

Spain4 sites, 4 recruiting

  • Vall d'Hebron Institute of Oncology

    Barcelona, Catalonia, 08035

    Gemma Mur, (+34) 932 54 34 50 ext. 8974

    Elena Garralda, MD

    Recruiting

  • Hospital Universitario Quirónsalud Madrid

    Madrid, Spain, 28223

    Micaela Belén Acosta, 919499716, mbelen@nextoncology.eu

    Valentina Boni, MD

    Recruiting

  • START Madrid FJD

    Madrid, 28040

    Manuel Pedregal, +34 91 550 48 00 ext. Ext: 2805

    Manuel Pedregal, MD

    Recruiting

  • Instituto de Investigacion Sanitaria, INCLIVA

    Valencia, 46010

    Susanna Roselló, MD, srosello@incliva.es

    Susana Roselló, MD

    Recruiting

Other trials in Spain

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C4

    Lillian Siu, MD, 416-946-2911

    Lillian Siu, MD

    Recruiting

Other trials in Canada

France1 site, 1 recruiting

  • Institute Gustave Roussy

    Villejuif, 94800

    Romain Di-Vincenzo, +33 1 42 11 58 31

    Aurelien Marabelle, MD

    Recruiting

Other trials in France

About this study

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)

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.

Read the 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).

Being tested
STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere)
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
Medical subject headings
Genital Neoplasms, Female, Urogenital Neoplasms, Lung Neoplasms, Neoplasms by Site, Papillomavirus Infections, Epstein-Barr Virus Infections, Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STAR0602Drug

    Also called Invikafusp alfa

    solution, intravenous infusion

  • Irinotecan (Camptosar)Combination product

    Also called Camptosar

    solution, intravenous infusion

  • Docetaxel (Taxotere)Combination product

    Also called Taxotere

    solution, intravenous infusion

Study groups in NCT05592626
Study groupRoleWhat they receive
Phase 1: Advanced Solid TumorsExperimentalDose Escalation; Intervention: Drug: STAR0602, Invikafusp alfa
Receives: Drug: STAR0602
Phase 2: Advanced Solid TumorsExperimentalDose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602, Invikafusp alfa
Receives: Drug: STAR0602; Combination Product: Irinotecan (Camptosar); Combination Product: Docetaxel (Taxotere)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: 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)

    Measured: Up to 3 years

Secondary outcomes (12)

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

    Measured: Up to 3 years

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

    Measured: Up to 3 years

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

    Measured: Up to 3 years

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

    Measured: Up to 3 years

  5. Phase 2 (Dose Expansion): Overall Survival (OS)

    Measured: Up to 3 years

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start4 Jan 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592626
Sponsor's protocol ID
CP-START-001
Other IDs
2023-505334-10-01, 2023
Acronym
START-001
Status last verified
Aug 2026
First submitted
13 Oct 2022
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sullivan RJ, Tschernia NP, Friedman CF, Herrera M, Sonpavde GP, He K, Italiano A, Marabelle A, Roulleaux-Dugage M, Danlos FX, Cabanas EG, Hernando-Calvo A, Pedregal M, Parikh A, Iyer G, Zakari A, Wherry EJ, Schlom J, Donahue RN, McCue S, Cross S, Srinivasan K, Benincosa L, Katragadda M, Shun Z, Chin K, Su Z, Liu K, Siu LL, Gulley JL. Bispecific dual T cell agonist invikafusp alfa in solid tumors: the phase 1/2 START-001 trial. Nat Med. 2026 Oct 23. doi: 10.1038/s41591-026-04711-0. Online ahead of print.

    PubMed 42919963

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing STAR0602, Irinotecan (Camptosar) and Docetaxel (Taxotere) in people with Advanced Solid Tumors and Genital Neoplasm, Female, run by Marengo Therapeutics, Inc. at 19 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Spain, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ke Liu, MD, PhD (+1 (617) 917-4980, kliu@marengotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1 (time frame: Cycle 1 (Cycle length= 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05592626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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