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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06293898
• Other study ID #: BL-M07D1-ST-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Urothelial Carcinoma

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