BL-M07D1 for HER2-Positive Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: SystImmune Inc.

Must not be taking: Chemotherapy, Immunotherapy, Antihypertensives, others

Disqualifiers: Severe heart disease, Autoimmune, CNS tumors, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

Will I have to stop taking my current medications?

The trial requires that you stop certain treatments like chemotherapy, biological therapy, and others at least 2 weeks before starting the study. If you're on medications for other conditions, the protocol doesn't specify, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug BL-M07D1 for HER2-positive cancer?

Research shows that treatments targeting HER2, like trastuzumab and lapatinib, have significantly improved outcomes for patients with HER2-positive breast cancer. New HER2-targeting drugs and combinations have led to better survival rates and long-term responses, suggesting that similar treatments could be effective. ^{1 2 3 4 5}

What makes the drug BL-M07D1 unique for treating HER2-Positive Cancer?

BL-M07D1 may involve targeting the B7 family of molecules, which are known to play a role in immune system regulation and tumor immunity. This approach could offer a novel mechanism by enhancing the body's immune response against cancer cells, potentially differing from standard treatments that do not focus on these pathways. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for adults with advanced tumors that express the HER2 protein, including cancers of the biliary tract, ovaries, cervix, endometrium, and bladder. Specific eligibility details are not provided but typically include health status and prior treatments.

Inclusion Criteria

My bladder cancer shows HER2 expression.

My endometrial cancer tests positive for HER2.

My cervical cancer is HER2 positive.

Exclusion Criteria

Participated in another clinical trial within 4 weeks or two half-lives (whichever is longer) prior to first dose of study treatment

I have been treated with topoisomerase 1 inhibitors.

I had another cancer but it has been in remission for the last 5 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BL-M07D1 to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) over a 21-day cycle

21 days

1 visit (in-person) per cycle

Dose Finding

Participants receive BL-M07D1 to identify two or more recommended doses for dose expansion

21 days

1 visit (in-person) per cycle

Dose Expansion

Participants receive BL-M07D1 at the recommended dose to further evaluate safety and efficacy

21 days

1 visit (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• BL-M07D1 (Monoclonal Antibodies)

Trial Overview The study is testing BL-M07D1's safety and effectiveness in treating HER2-positive tumors. It's an open-label trial meaning everyone knows they're getting BL-M07D1; there's no placebo or comparison group.

Participant Groups

Group I: BL-M07D1 administered Day 1 of a 21-day cycle Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

SystImmune Recruiting Center New York, NY

SystImmune Recruiting Center Nashville, TN

SystImmune Recruiting Center Fairfax, VA

SystImmune Recruiting Site Houston, TX

Who Is Running the Clinical Trial?

SystImmune Inc. Lead Sponsor

References

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

Emerging strategies for the dual inhibition of HER2-positive breast cancer. [2019] To review the recently published trials to help us refine and optimize the use of approved HER2-targeted agents (trastuzumab and lapatinib) and highlight future combination strategies for the treatment of HER2-positive breast cancer.

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

Systemic Therapy for HER2-Positive Metastatic Breast Cancer: Moving Into a New Era. [2022] Patients with HER2-positive breast cancer account for approximately 15% to 20% of all breast cancers and represent one of the most aggressive breast cancer subtypes. Survival rates of patients with metastatic disease have improved dramatically and progressively. Many new agents have been developed, and long-term follow-up from trials of anti-HER2 agents has shown long-term responses. The availability of novel, highly active anti-HER2 treatments, together with the ongoing development of promising diagnostic tools, will offer the unprecedented opportunity to raise cure rates. Our ultimate goal is to tailor treatment intensity to disease and patient characteristics, hopefully increasing the fraction of cured patients while minimizing the risk for overtreatment. If conducted rationally and carefully, this plan has the potential to break a decades-long paradigm, leading to a new, precise era of treatment of HER2-positive breast cancer.

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

Updates on the treatment of human epidermal growth factor receptor type 2-positive breast cancer. [2020] To review the most recent developments in the treatment of human epidermal growth factor receptor type 2 (HER2)-positive breast cancer with novel HER2-targeting agents and combinations that have significantly improved clinical outcomes.

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

Overcoming treatment challenges in advanced breast cancer. [2018] To describe new clinical findings, efficacy, and safety regarding the use of targeted agents in the treatment of HER2-positive metastatic breast cancer.

5. England pubmed.ncbi.nlm.nih.gov

Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. [2022] HER2-targeted treatments have improved outcomes in patients with HER2-positive breast cancer in the neoadjuvant, adjuvant, and metastatic settings; however, some patients remain at risk of relapse or death for many years after treatment of early-stage disease. Therefore, new strategies are needed. We did a phase 3 trial to assess a neoadjuvant regimen for HER2-positive breast cancer that replaces traditional systemic chemotherapy with targeted treatment.

6. China pubmed.ncbi.nlm.nih.gov

[Establishment and growth characteristics of mouse lung cancer B₇ fusion cells]. [2010] To ameliorate expression B₇ molecule of tumor cell.

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

B7DC/PDL2 promotes tumor immunity by a PD-1-independent mechanism. [2022] B7H1 (PDL1) and B7DC (PDL2) are two new members of the B7 family that can interact with PD-1, a putative negative regulator for immune function. Recent studies have provided evidence for inhibitory functions of both members via PD-1. Meanwhile, compelling evidence exists for costimulatory function of both members. Here we demonstrate that expression of B7DC on the tumor cells promotes CD8 T cell-mediated rejection of tumor cells, at both the induction and effector phase of antitumor immunity. Moreover, B7DC binds to PD-1(-/-) cells and enhances T cell killing in a PD-1-independent mechanism. Our results demonstrate a novel pathway for B7DC to promote tumor immunity and may reconcile the apparently contradictory findings on the function of B7DC.

8. England pubmed.ncbi.nlm.nih.gov

Doxorubicin downregulates cell surface B7-H1 expression and upregulates its nuclear expression in breast cancer cells: role of B7-H1 as an anti-apoptotic molecule. [2022] B7-H1 (PD-L1, CD274) is a T cell inhibitory molecule expressed in many types of cancer, leading to immune escape of tumor cells. Indeed, in previous reports we have shown an association of B7-H1 expression with high-risk breast cancer patients.

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

B7x and myeloid-derived suppressor cells in the tumor microenvironment: A tale of two cities. [2021] A new study demonstrates the tumorigenic functions of B7x and reveals a link between B7x and myeloid-derived suppressor cells (MDSCs) within the tumor microenvironment. We propose that the binding of B7x to a hitherto unidentified receptor on MDSCs may stimulate their proliferation and/or immunosuppressive functions, hence promoting tumor growth.

10. Saudi Arabia pubmed.ncbi.nlm.nih.gov

The immunoinhibitory B7-H1 molecule as a potential target in cancer: killing many birds with one stone. [2022] Over expression of B7-H1 (also named PDL-1 or CD 274) molecule in cancer has been linked to worse prognosis and resistance to anti-cancer therapies in several malignancies. In this review, we update on the expression of B7-H1 molecule in solid and hematological malignancies. We also describe the possible mechanisms by which this molecule inhibits/downregulates the immune response to cancer cells. Finally, we highlight current and future potential therapeutic strategies that can be further developed to target this molecule.