Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
Breast Cancer
Cervical Cancer
Esophogeal Cancer
Lung Cancer
Ovarian Cancer
Stomach/ Gastric Cancer
18 Years and older, Male and Female
BL-M07D1-ST-101 (primary)
NCI-2024-07363
Summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of
BL-M07D1 in patients with HER2 expressing advanced tumors.
Objectives
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. .
Eligibility
- Age: =18 years
- Has a life expectancy of =3 months
- Has documented locally advanced or metastatic HER2-expressing (IHC 1+ to 3+ and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant/neoadjuvant treatment, with documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease and have progressed or refractory to standard of care, including:
- Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)
- Cohort 2: Subjects with HER2 expression in cervical cancers (CC)
- Cohort 3: Subjects with HER2 expression in ovarian cancers (OC)
- Cohort 4: Subjects with HER2 expression in urothelial cancers (UC)
- Cohort 5: Subjects with HER2 expression in biliary tract cancers (BTC)
- Cohort 6: Subjects with HER2 expression in breast cancer (BC)
- Cohort 7: Subjects with HER2 expression in lung cancer (LC)
- Cohort 8: Subjects with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers
- Agree to provide existing tumor samples
- Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
- Toxicity of previous antitumor therapy has returned to Grade =1
- Has no serious cardiac dysfunction, left ventricular ejection fraction =50%
- Has adequate organ function before registration
- Coagulation function: international normalized ratio (INR) =1.5×ULN, and activated partial thromboplastin time (APTT) =1.5 ULN
- Urinary protein =2+ or =1000 mg/24 hours
- 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.
- 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)
Treatment Sites in Georgia
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