Invikafusp Alfa + Sacituzumab Govitecan for Breast Cancer

(START-002 Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Invikafusp Alfa + Sacituzumab Govitecan for breast cancer?

Sacituzumab govitecan has shown effectiveness in improving progression-free survival and overall survival in patients with certain types of breast cancer, such as hormone receptor-positive and triple-negative breast cancer, compared to standard chemotherapy. This suggests it may be a promising component in the treatment of breast cancer. ^{1 2 3 4 5}

What is known about the safety of Sacituzumab Govitecan in humans?

Sacituzumab Govitecan has been associated with side effects such as diarrhea, neutropenia (low white blood cell count), nausea, fatigue, hair loss, anemia (low red blood cell count), constipation, and vomiting. Serious adverse events like colitis (inflammation of the colon), pneumonitis (lung inflammation), febrile neutropenia (fever with low white blood cell count), pyrexia (fever), sepsis (severe infection), dehydration, and diarrhea have been identified as risk factors for hospitalization. ^{1 3 4 5 6}

What makes the drug Invikafusp Alfa + Sacituzumab Govitecan unique for breast cancer treatment?

This drug combination is unique because it includes Sacituzumab Govitecan, an antibody-drug conjugate that targets Trop-2, a protein found on many cancer cells, and delivers a chemotherapy agent directly to these cells, potentially improving effectiveness and reducing side effects compared to traditional chemotherapy. ^{1 2 3 5 7}

Eligibility Criteria

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 one of the specified types and stages listed.

My cancer type might be considered for the trial as new information becomes available.

I am not currently receiving treatment for brain or spinal cord disease.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Role of sacituzumab govitecan in solid tumors. [2023]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Postmarketing safety of Sacituzumab govitecan: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). [2023]

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]

7. United States 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. [2022]