BL-M17D1 for Breast Cancer

Not currently recruiting at 11 trial locations

Overseen By Lien Huzzy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SystImmune Inc.

Must not be taking: CYP3A4 inhibitors, P-gp inducers

Disqualifiers: Heart disease, Autoimmune diseases, Hypertension, Lung diseases, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called BL-M17D1 for various advanced or metastatic cancers with a specific protein marker known as HER2. The main aim is to assess the drug's safety, tolerability, how the body processes it, and its effectiveness against tumors. Participants should have a HER2-positive or HER2-mutant tumor that cannot be treated with standard surgery or radiation and should have already tried other treatments without success. This trial offers a chance for those with these specific cancer types who seek new treatment options. 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 therapy.

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

The trial requires you to stop certain medications, like chemotherapy and some other cancer treatments, at least 4 weeks before starting. You also can't use strong inhibitors or inducers of specific enzymes within 2 weeks before starting. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that BL-M17D1 is likely to be safe for humans?

Research shows that BL-M17D1 remains in the early stages of testing for safety in humans. Researchers are closely studying the treatment to assess how well people tolerate it and to identify any side effects. In similar studies with BL-M17D1, they are examining how the body processes the drug and its effects on cancer cells. Detailed information on specific side effects or safety findings for BL-M17D1 is not yet available. However, as it is in an early phase of clinical trials, researchers continue to collect this crucial safety information. Participants in this trial will contribute to understanding the safety of BL-M17D1 for treating HER2-positive or mutant cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BL-M17D1 for breast cancer because it introduces a potentially groundbreaking approach. Unlike standard treatments like chemotherapy or hormone therapy, which often target rapidly dividing cells or hormone receptors, BL-M17D1 may work through a novel mechanism that directly targets specific cancer pathways. This targeted approach could lead to fewer side effects and improved outcomes for patients. Additionally, the administration of BL-M17D1 via IV infusion on specific days every three weeks offers a consistent and manageable treatment schedule, which might improve patient adherence and quality of life.

What evidence suggests that BL-M17D1 might be an effective treatment for breast cancer?

Research shows that BL-M17D1, a new treatment, may help treat certain solid tumors with specific HER2 characteristics. This treatment combines a special protein with a drug to directly target and destroy cancer cells. Early studies have examined its safety and how the body processes it, showing initial signs of cancer-fighting potential. The main focus has been on patients with advanced or spreading tumors, highlighting potential benefits. This targeted approach might surpass traditional treatments, especially for those with certain HER2-related cancers. Participants in this trial will receive BL-M17D1 in different dosing regimens to evaluate its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

Sarah Tannenbaum, MD, MSc

Principal Investigator

SystImmune Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors expressing or carrying mutations in HER2. Participants must have a life expectancy of at least 3 months, measurable cancer lesions, good physical health (ECOG PS 0-1), and stable organ function. They should not have severe side effects from past treatments (except hair loss and controlled hormone issues) and agree to provide tumor samples.

Inclusion Criteria

My cancer is HER2-positive, advanced, and cannot be cured with surgery or radiation.

I have signed the informed consent and agree to follow the study rules.

My blood tests show normal white blood cells, platelets, and hemoglobin levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

BL-M17D1 is administered on Day 1 and Day 8 by IV infusion every 3 weeks to determine the maximum tolerated dose

21 days per cycle

2 visits per cycle (in-person)

Dose Finding

BL-M17D1 is administered on Day 1 and Day 8 by IV infusion every 3 weeks to find the optimal dose

21 days per cycle

2 visits per cycle (in-person)

Dose Expansion

BL-M17D1 is administered on Day 1 and Day 8 by IV infusion every 3 weeks to expand the study to more participants

21 days per cycle

2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• BL-M17D1

Trial Overview The study tests BL-M17D1's safety, tolerability, how the body processes it, and its effectiveness against various HER2-positive or mutant cancers like thyroid, breast, bladder cancer etc. It's an early-phase trial focusing on patients who've had prior treatments but need new options.

How Is the Trial Designed?

Group I: Dose Finding Experimental Treatment 1 Intervention

Beginning with Cycle 1, BL-M17D1 will be administered on Day 1 and Day 8 by (IV) infusion every 3 weeks (D1,D8 Q3W)

Group II: Dose Expansion Experimental Treatment 1 Intervention

Beginning with Cycle 1, BL-M17D1 will be administered on Day 1 and Day 8 by (IV) infusion every 3 weeks (D1,D8 Q3W)

Group III: Dose Escalation Experimental Treatment 1 Intervention

Beginning with Cycle 1, BL-M17D1 will be administered on Day 1 and Day 8 by (IV) infusion every 3 weeks (D1,D8 Q3W)

Who Is Running the Clinical Trial?

SystImmune Inc.

Lead Sponsor

Trials

23

Recruited

1,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06503783

A Study of BL-M17D1 in Patients With Locally Advanced or ... Expected survival time ≥3 months;; Patients with locally advanced or metastatic HER2-positive/negative breast cancer and other solid tumors;; Agree to provide ...

2. bcan.org bcan.org/clinicaltrials/bl-m17d1-w-her2-expressing-mutant-advanced-or-metastatic-solid-tumors/

BL-M17D1 w/HER2-Expressing/Mutant Advanced or ... The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant ...

3. targetedonc.com targetedonc.com/view/fda-grants-clearance-for-phase-1-trial-of-bl-m17d1-in-solid-tumors

FDA Grants Clearance for Phase 1 Trial of BL-M17D1 ... The FDA has granted clearance to an IND application for BL-M17D1, an ADC, for the potential treatment of patients with advanced or metastatic solid tumors.

4. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT06714617

MTS Trials - BreastCancerTrials.org Purpose: To study the safety, effects (good and bad), and anti-cancer activity of BL-M17D1, an experimental antibody drug conjugate. Who is this for?:

5. clin.larvol.com clin.larvol.com/trial-detail/NCT06503783

BL-M17D1-101 / NCT06503783 Outcome Measure, Measure Description, Time Frame. Phase Ia: Dose limiting toxicity (DLT), DLTs are assessed according to NCI-CTCAE v5.0 during the first ...

6. withpower.com withpower.com/trial/phase-1-endometrial-neoplasms-2-2025-9c50e

BL-M17D1 for Breast Cancer The study tests BL-M17D1's safety, tolerability, how the body processes it, and its effectiveness against various HER2-positive or mutant cancers.

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-bl-m17d1-in-patients-with-locally-advanced-or-metastatic-her2-positive-negative-breast-ca

A Study of BL-M17D1 in Patients With Locally Advanced or ... This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, ...