Invikafusp Alfa + Sacituzumab Govitecan for Breast Cancer

(START-002 Trial)

Recruiting at 7 trial locations

Overseen By Kevin Chin, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Marengo Therapeutics, Inc.

Must not be taking: Immune-suppressive drugs

Disqualifiers: Autoimmune disease, Cardiovascular, Infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination treatment for breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study tests the safety and effectiveness of Invikafusp Alfa (an experimental treatment) in combination with Sacituzumab Govitecan. Suitable participants have breast cancer that has returned or progressed, specifically types like triple-negative or hormone receptor-positive/HER2-negative, and do not have ongoing symptoms from brain metastases. The goal is to determine if this combination can help control the cancer and improve patient outcomes. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on more than 10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days before starting the study treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of Invikafusp Alfa and Sacituzumab Govitecan is generally well-tolerated by patients. Sacituzumab Govitecan, already approved by the FDA for some cancers, can cause side effects like nausea and tiredness, but many people manage these well. Invikafusp Alfa remains under study, so not all its side effects are known. However, the trial's progression to early and middle stages indicates that earlier tests found the treatment safe enough to continue. While any treatment carries risks, this combination has shown promise in being manageable for patients so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Invikafusp Alfa (STAR0602) combined with Sacituzumab Govitecan for breast cancer because these treatments offer a fresh approach to targeting cancer cells. Unlike traditional chemotherapy, which attacks both cancerous and healthy cells, Sacituzumab Govitecan is an antibody-drug conjugate that directly delivers chemotherapy to cancer cells, minimizing damage to normal cells. Invikafusp Alfa, on the other hand, provides a novel mechanism potentially enhancing the immune system's ability to fight tumors. This combination aims to improve treatment effectiveness with potentially fewer side effects, offering new hope for patients with advanced solid tumors.

What evidence suggests that Invikafusp Alfa + Sacituzumab Govitecan might be an effective treatment for breast cancer?

Research has shown that combining Invikafusp Alfa with Sacituzumab Govitecan holds promise for treating advanced solid tumors. Participants in this trial will receive this combination therapy. Invikafusp Alfa has effectively controlled the disease and shrunk tumors, even those resistant to other treatments. In some patients, up to 33.3% have seen their tumors respond well to this treatment. Early findings suggest that this combination can partially shrink tumors. It targets specific parts of T-cells, a type of immune cell, potentially enhancing the body's ability to fight cancer. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced solid tumors, including specific breast, ovarian, prostate cancers, and non-small cell lung cancer. Participants should have tried standard treatments without success or experienced severe side effects. They must not be receiving CNS disease treatment beyond a low dose of steroids and should not have leptomeningeal disease or spinal cord compression.

Inclusion Criteria

My cancer is advanced, can't be surgically removed, and standard treatments have failed or caused severe side effects.

My cancer has a high number of mutations or is linked to a virus.

My cancer is one of the specified types and stages listed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Safety Run-In

Participants receive STAR0602 in combination with Sacituzumab Govitecan to assess safety and determine the recommended expansion dose

Duration not specified

Phase 2 Cohort Expansion

Participants receive STAR0602 in combination with Sacituzumab Govitecan at the recommended expansion dose to evaluate efficacy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Invikafusp Alfa (STAR0602)
• Sacituzumab Govitecan

Trial Overview The study tests Invikafusp alfa (STAR0602) combined with Sacituzumab Govitecan in patients with advanced solid tumors. It's an early-phase trial to assess safety and effectiveness. STAR0602 targets T cells to fight cancer while SG is a chemotherapy drug conjugate that delivers toxins directly to tumor cells.

How Is the Trial Designed?

Group I: Phase 2 Cohort Expansion: Advanced Solid Tumors Experimental Treatment 2 Interventions

Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1

Group II: Phase 1 Safety Run-In: Advanced Solid Tumors Experimental Treatment 2 Interventions

Interventions: STAR0602 + Sacituzumab Govitecan

Who Is Running the Clinical Trial?

Marengo Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

420+

Published Research Related to This Trial

Sacituzumab govitecan (SG) is an FDA-approved antibody-drug conjugate that has shown significant efficacy in treating metastatic triple-negative breast cancer, improving health-related quality of life and prolonging progression-free and overall survival in patients who have undergone multiple prior therapies.

Ongoing clinical trials are exploring the potential of SG for broader applications, including neoadjuvant and adjuvant therapies, combinations with immunotherapy, and treatment of various solid tumors, indicating its promise as a versatile cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of sacituzumab govitecan in solid tumors. Veeraballi, S., Khawar, Z., Aslam, HM., et al.[2023]

Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, showed promising therapeutic activity in a phase I trial with 25 patients suffering from various metastatic solid cancers, achieving partial responses in two patients and stable disease in 16 others.

The maximum tolerated dose was determined to be 12 mg/kg for the first cycle, with lower doses (8 and 10 mg/kg) being safer for extended treatment, leading to acceptable toxicity levels and disease control for up to 36 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Starodub, AN., Ocean, AJ., Shah, MA., et al.[2022]

In a phase 3 trial involving 543 patients with pretreated, endocrine-resistant HR+ and HER2- metastatic breast cancer, sacituzumab govitecan significantly improved overall survival compared to chemotherapy, with a median survival of 14.4 months versus 11.2 months.

Sacituzumab govitecan also showed a higher objective response rate (21% vs 14%) and better quality of life outcomes, indicating it is a promising new treatment option for patients with limited alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Rugo, HS., Bardia, A., Marmé, F., et al.[2023]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.

The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]

In a study of 43 patients with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan, the median overall survival was 13.1 months, indicating its effectiveness in a real-world setting.

Common adverse events included alopecia, diarrhea, and neutropenia, with 27.9% of patients experiencing Grade 3 neutropenia, highlighting the need for careful management of side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of sacituzumab govitecan in patients with metastatic triple-negative breast cancer in real-world settings: first observations from an interdisciplinary breast cancer centre in Germany. Reinisch, M., Bruzas, S., Spoenlein, J., et al.[2023]

Sacituzumab govitecan (SG) has been approved in the EU for treating adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have undergone at least two prior systemic therapies, showing significant improvements in progression-free survival (4.8 months vs. 1.7 months) and overall survival (11.8 months vs. 6.9 months) compared to treatment of physician's choice.

The most common side effects of SG include diarrhea, neutropenia, nausea, fatigue, alopecia, anemia, constipation, and vomiting, occurring in more than 30% of patients, indicating that while SG is effective, it also has notable adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer. Michaleas, S., Moreno Oliver, A., Mueller-Berghaus, J., et al.[2022]

A total of 1,884 adverse event reports related to sacituzumab govitecan were analyzed, identifying 114 adverse event signals, with most occurring within 30 days of treatment initiation, highlighting the importance of monitoring for early reactions.

Risk factors for hospitalization due to adverse events included being male and experiencing conditions like colitis, febrile neutropenia, and sepsis, indicating specific patient profiles that may require closer observation during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing safety of Sacituzumab govitecan: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). Li, X., Zhang, L., Hu, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06827613

NCT06827613 | A Study of Invikafusp Alfa (STAR0602), ... 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, ...

2. onclive.com onclive.com/view/invikafusp-alfa-boasts-high-disease-control-rate-in-checkpoint-inhibitor-resistant-solid-tumors

Invikafusp Alfa Boasts High Disease Control Rate in ... Invikafusp alfa demonstrated significant tumor regression in TMB-H/MSI-H tumors resistant to immune checkpoint blockade, with ORRs up to 33.3% ...

3. trialx.com trialx.com/clinical-trials/listings/296239/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 Study of Invikafusp Alfa (STAR0602), a Selective T Cell ... 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, ...

4. trial.medpath.com trial.medpath.com/news/93d4e8af4378ac45/marengo-therapeutics-advances-phase-2-expansion-of-invikafusp-alfa-trodelvy-combination-for-metastatic-breast-cancer

Marengo Therapeutics Advances Phase 2 Expansion of ... Early data from the study has revealed signs of anti-tumor activity, including confirmed partial responses and tumor regressions in patients ...

5. withpower.com withpower.com/trial/phase-2-triple-negative-locally-advanced-non-resectable-breast-cancer-2-2025-c47da

Invikafusp Alfa + Sacituzumab Govitecan for Breast Cancer Trial Overview The study tests Invikafusp alfa (STAR0602) combined with Sacituzumab Govitecan in patients with advanced solid tumors. It's an early-phase trial ...

6. prnewswire.com prnewswire.com/news-releases/marengo-therapeutics-advances-start-002-clinical-trial-into-phase-2-cohort-expansion-evaluating-invikafusp-alfa-with-trop2-directed-adc-trodelvy-in-metastatic-breast-cancer-302559912.html

Marengo Therapeutics Advances STARt-002 Clinical Trial ... STARt-002 (NCT06827613) is a Phase 1b/2, open-label, multicenter study investigating the combination of invikafusp alfa and TRODELVY® in ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02223

A Study of Invikafusp Alfa (STAR0602), a Selective T Cell ... 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, ...