Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors

NCT06714617 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BL-M17D1-ST-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Breast Cancer Stage III; HER2-positive Metastatic Breast Cancer; Unresectable Breast Carcinoma; Her2-Positive; HER2 Gene Mutation; Gastroesophageal-junction Cancer; Non Small Cell Lung Cancer; Endometrial Neoplasms; Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer; Urothelial Carcinoma Bladder; Solid Tumor, Adult; Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• Participants with Dose-limiting toxicities

  Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: Hematologic toxicities * Grade 4 neutrophil count decreased lasting \>7 days * Grade ≥3 febrile neutropenia of any duration * Grade ≥3 platelet count decreased with clinically significant hemorrhage * Grade 4 thrombocytopenia lasting \>7 days Nonhematologic toxicities * Death not clearly related to disease progression or extraneous cause * Hy's law cases * Grade ≥3 nonhematologic toxicities

  1 Year

• Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)

  Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)

  1 Year

• To determine the MTD if reached or MAD and two or more RDEs of BL-M17D1

  MTD, MAD, and RDE

  1 Year

Study Arms (3)

Dose Escalation

EXPERIMENTAL

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

Drug: BL-M17D1

Dose Finding

EXPERIMENTAL

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

Drug: BL-M17D1

Dose Expansion

EXPERIMENTAL

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

Drug: BL-M17D1

Interventions

BL-M17D1 DRUG

The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M17D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks.

Dose Escalation; Dose Expansion; Dose Finding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consent form
• Age ≥18 years.
• Weighs more than 40 kg. For doses \<0.3 mg/kg, subject must weigh ≥70 kg.
• Has a life expectancy of ≥3 months.
• Has documented locally advanced or metastatic HER2-positive solid tumor(s) (IHC 1+ to 3+ or in situ hybridization \[ISH\] positive) or HER2-mutant tumor specimen not amenable to curative surgery or radiation and has received at least 1 line of standard therapy in the advanced/metastatic setting, or for which no standard treatment is available, including:
• Cohort 1: HER2-positive breast cancer (BC);
• Cohort 2: HER2-positive gastric/gastroesophageal junction cancer (GC/GEJ);
• Cohort 3: HER2-positive or HER2-mutant non-small cell lung cancer (NSCLC);
• Cohort 4: HER2-positive endometrial cancer (EC);
• Cohort 5: HER2-positive ovarian cancer (OC), including fallopian tube cancer and primary peritoneal cancer;
• Cohort 6: HER2-positive urothelial cancers (UC);
• Cohort 7: Other HER2-positive solid tumors as approved by the medical monitor. Note: For indications in which a HER2-directed therapy is approved, the approved treatment is recommended although not mandated, at the discretion of the investigator.
• Agree to provide most recent existing tumor samples (FFPE tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression:
• In dose escalation and dose finding: archival tissue or fresh biopsy. If no archival tissue is available or it is not possible to obtain a fresh tissue biopsy, medical monitor approval is required;
• In dose expansion: an FFPE block or slides from fresh biopsy or the most recent archival tissue is required.

You may not qualify if:

• Subjects who meet any of the following criteria will not be eligible for participation in this study:
• Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration.
• Concomitant use of strong inhibitors and inducers of any CYP3A4 enzyme or P-gp transporter system within 2 weeks or 5 half-lives (whichever is longer) prior to the first administration and throughout all parts of the study.
• History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment.
• Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type 1 diabetes, hypothyroidism that can be controlled by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).
• Other prior malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening.
• Poorly controlled hypertension by two types of antihypertensive drugs (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg).
• Advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension etc.
• Have a history of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Stroke or transient ischemic attack (TIA) within 6 months before enrollment.
• Thromboembolic event (eg, deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment.
• Primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the IP. Patients on low dose corticosteroids (\<10 mg prednisone or equivalent/day) may participate.
• Pre-existing ≥Grade 2 peripheral neuropathy.
• Subjects who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M17D1.
• Subjects who are receiving treatment with systemic glucocorticoids \>10 mg/day equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg/day equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted.

Sponsors & Collaborators

• SystImmune Inc.: lead

Study Sites (9)

SCRI-Denver HealthOne

Denver, Colorado, 37203, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

SCRI-Florida Cancer Center Specialists Lake Mary

Lake Mary, Florida, 32746, United States

Location

Hematology Oncology Associates of the Treasure Cost

Port Saint Lucie, Florida, 34952, United States

Location

SCRI-Florida Cancer Center Specialists Sarasota

Sarasota, Florida, 34236, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

SCRI-Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

SCRI-Oncology Partners

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Endometrial Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Sarah Tannenbaum, MD, MSc

  SystImmune Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)