BL-M17D1 for Breast Cancer

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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Sarah Tannenbaum, MD, MSc

Principal Investigator

SystImmune Inc.

Lien Huzzy

Principal Investigator

SystImmune Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+