Triple Negative Locally Advanced Non-resectable Breast CancerPhase 1/2START-002NCT06827613
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
A Phase 1/2 study testing STAR0602 and Sacituzumab Govitecan (SG) in people with Triple Negative Locally Advanced Non-resectable Breast Cancer and HR+, HER2-, Advanced Breast Cancer, run by Marengo Therapeutics, Inc. at 8 sites in 2 countries.
Trial summary
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
- What is being tested?
- STAR0602 and Sacituzumab Govitecan (SG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 24 Mar 2025to Jan 2028
- 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
- Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
- Tumor Type:
- mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC
- HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer
- 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 (eg, surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression.
Who cannot join
- 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
Show all 18Show fewer
- 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 intervention
- Unhealed wounds from surgery or injury
- 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 intervention.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention 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)
- Treatment with >10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Steven Isakoff, MD, PhD, MMSC, 617-726-6500
Steven Isakoff, MD, PhD, MMSC
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43212
Paige A Hayes, 614-688-6355, paige.hayes@osumc.edu
Margaret Gatti-Mays, MD, MPH, FACP
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Stephanie Kim, MSN, RN, 323-865-0240, stephanie.kim2@med.usc.edu
Anastasia Martynova, MD
- Recruiting
UCLA Health
Los Angeles, California, 90095
Bhavisha Tailor, 310-998-4747 ext. 16907, BTailor@mednet.ucla.edu
Kelly E McCann, MD, PhD
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Kate Hall, 629-250-9081, kate.schiesser@scri.com
Erika Hamilton, MD
- Recruiting
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, 78229
Jonah Crayton, 210-450-1000, craytonj@uthscsa.edu
Virginia Kaklamani, MD DSc
Canada2 sites, 2 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Philippe Bedard, MD, FRCPC, philippe.bedard@uhn.ca
Philippe Bedard, MD, FRCPC
- Recruiting
BC Cancer
Vancouver, British Columbia, V5Z 1K1
Rahma Osman, 604-877-6000 ext. 2825, rahma.osman@bccancer.bc.ca
Nathalie LeVasseur, MD
About this study
Official title: A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.
- Conditions
- Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
- Being tested
- STAR0602, Sacituzumab Govitecan (SG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR0602Drug
solution, intravenous infusion
Sacituzumab Govitecan (SG)Drug
intravenous infusion, 10mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Safety Run-In: Advanced Solid Tumors | Experimental | Interventions: STAR0602 + Sacituzumab Govitecan Receives: Drug: STAR0602; Drug: Sacituzumab Govitecan (SG) |
| Phase 2 Cohort Expansion: Advanced Solid Tumors | Experimental | Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1 Receives: Drug: STAR0602; Drug: Sacituzumab Govitecan (SG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
Measured: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events
Measured: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)
Proportion of participants who have a complete response (CR) or partial response (PR)
Measured: Up to 3 years
Secondary outcomes (8)
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR)
Measured: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR)
Proportion of participants who have a complete response (CR) or partial response (PR) or stable disease (SD)
Measured: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS)
Measured: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS)
Measured: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Maximum Observed Concentration (Cmax) for STAR0602
Measured: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Area Under the Concentration Curve (AUC) for STAR0602
Measured: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Total Body Clearance (CL) for STAR0602
Measured: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Volume of Distribution (Vd) for STAR0602
Measured: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start24 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Locally Advanced Non-resectable Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marengo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827613
- Sponsor's protocol ID
- START-002
- Acronym
- START-002
- Status last verified
- Sep 2025
- First submitted
- 28 Jan 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)
- ClinicalTrials.gov ID
- NCT06827613
- Acronym / sponsor ID
- START-002 / START-002
- Conditions
- Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marengo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Safety Run-In: Advanced Solid Tumors | Experimental | Drug: STAR0602, Drug: Sacituzumab Govitecan (SG)Interventions: STAR0602 + Sacituzumab Govitecan |
| Phase 2 Cohort Expansion: Advanced Solid Tumors | Experimental | Drug: STAR0602, Drug: Sacituzumab Govitecan (SG)Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
- Tumor Type:
- 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 (eg, surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression.
Key exclusion criteria (18 listed)
- History of known autoimmune disease with exceptions of:
- Major surgery or traumatic injury within 8 weeks before first dose of study intervention
- Unhealed wounds from surgery or injury
- 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 intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR0602solution, intravenous infusion | Drug | Phase 1 Safety Run-In: Advanced Solid Tumors, Phase 2 Cohort Expansion: Advanced Solid Tumors |
| Sacituzumab Govitecan (SG)intravenous infusion, 10mg/kg | Drug | Phase 1 Safety Run-In: Advanced Solid Tumors, Phase 2 Cohort Expansion: Advanced Solid Tumors |
Primary outcome
Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
Time frame: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)
Time frame: Up to 3 years
Proportion of participants who have a complete response (CR) or partial response (PR)
8 secondary outcomes
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Maximum Observed Concentration (Cmax) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Area Under the Concentration Curve (AUC) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Total Body Clearance (CL) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Volume of Distribution (Vd) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STAR0602 and Sacituzumab Govitecan (SG) in people with Triple Negative Locally Advanced Non-resectable Breast Cancer and HR+, HER2-, Advanced Breast Cancer, run by Marengo Therapeutics, Inc. at 8 sites in 2 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 6 inclusion and 18 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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 Kevin Chin, MD, MS (617-276-5734, kchin@marengotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs) (time frame: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan). 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?
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 24 Sep 2025.