Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

March 1, 2024 updated by: SystImmune Inc.

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BL-M07D1-ST-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M07D1 in participants with HER2 expressing advanced malignant solid tumors.

This study will be conducted in three parts (dose escalation, dose finding and dose expansion). Dosing will be conducted on Day 1 of a continuous 21-day treatment cycle. .

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • SystImmune Recruiting Site
        • Contact:
          • SystImmune

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: ≥18 years
  2. Has a life expectancy of ≥3 months

  3. Has documented locally advanced or metastatic HER2 expressing (IHC 1+ to 3+) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy

    1. Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)
    2. Cohort 2: Subjects with HER2 expression in cervical cancers (CC)
    3. Cohort 3: Subjects with HER2 expression in ovarian cancers (OC)
    4. Cohort 4: Subjects with HER2 expression in urothelial cancers (UC)
    5. Cohort 5: Subjects with HER2 expression in biliary tract cancers (BTC)
  4. Agree to provide existing tumor samples
  5. Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1
  6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
  7. Toxicity of previous antitumor therapy has returned to Grade ≤1
  8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%
  9. Has adequate organ function before registration
  10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN
  11. Urinary protein ≤2+ or ≤1000 mg/24 hours
  12. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy test must be negative and subject must be nonlactating.
  13. Must agree to use adequate contraceptive measures during the treatment and for 6 months after the end of treatment for all subjects (regardless of gender)

Exclusion Criteria:

  1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 2 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
  2. Subjects with history of severe heart disease
  3. Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block
  4. Subjects who received treatment with topoisomerase 1 inhibitors as a free form or as other formulations
  5. Active autoimmune diseases and inflammatory diseases
  6. Other malignant tumors diagnosed within 5 years prior to the first administration considered to be in remission
  7. Subjects with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg)
  8. Subjects who have Grade 3 lung disease or a history of interstitial lung disease
  9. Deep vein thrombosis or pulmonary embolism unless under adequate anticoagulant treatment
  10. Patients with 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 investigational product (IP). Patients on low dose corticosteroids (<20 mg prednisone or equivalent/day) may participate.
  11. Subjects who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL M07D1
  12. Subjects who have a history of autologous or allogeneic stem cell transplantation
  13. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2
  14. Known human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > the lower limit of detection) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > the lower limit of detection)
  15. Subjects with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
  16. Participated in another clinical trial within 4 weeks or two half-lives (whichever is longer) prior to first dose of study treatment
  17. Other conditions that the investigator believes are not suitable for participating in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BL-M07D1 administered Day 1 of a 21-day cycle
Drug: BL-M07D1
Drug: BL-M07D1 The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of safety
Time Frame: Though study completion, an average of 24 months
The number of patients with dose-limiting toxicities, serious adverse events, treatment-emergent adverse events, physical exam findings, vital signs, laboratory tests, ECG parameters and echocardiograph
Though study completion, an average of 24 months
To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1
Time Frame: 21 Days
Determine the highest BL-M07D1 dose level at which subjects do not experience a DLT during the DLT evaluation period and highest BL-M07D1 dose administered in the event and MTD cannot be defined.
21 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SystImmune Inc.

Investigators

  • Study Director: Clinical Leader, SystImmune Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2024

Primary Completion (Estimated)

August 24, 2025

Study Completion (Estimated)

August 24, 2027

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL-M07D1-ST-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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