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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06293898
Other study ID # BL-M07D1-ST-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 9, 2024
Est. completion date August 24, 2027

Study information

Verified date March 2024
Source SystImmune Inc.
Contact Elizabeth D Lotz
Phone 18432249830
Email elizabeth.lotz@systimmune.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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. .


Recruitment information / eligibility

Status Recruiting
Enrollment 280
Est. completion date August 24, 2027
Est. primary completion date August 24, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States SystImmune Recruiting Site Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
SystImmune Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Summary of safety 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
Primary 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 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
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