A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors

Official title

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Solid Tumors

Overview

Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors.

Interventions

• Drug BL-M07D1
  BL-M07D1 was administered by intravenous infusion every 3 weeks in 3-week cycles.

Primary outcome measures

• Phase Ib: Recommended Phase II Dose (RP2D) [Time frame: Up to approximately 24 months]
• Phase II: Objective response rate (ORR) [Time frame: Up to approximately 24 months]

Secondary outcome measures (12)

• Phase Ib/II: Treatment-Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]
• Phase Ib: Objective response rate (ORR) [Time frame: Up to approximately 24 months]
• Phase Ib/II: Disease control rate (DCR) [Time frame: Up to approximately 24 months]
• Phase Ib/II: Duration of response (DOR) [Time frame: Up to approximately 24 months]
• Phase II: Progression-free survival (PFS) [Time frame: Up to approximately 24 months]
• Phase Ib/II: Cmax [Time frame: Up to approximately 24 months]
• Phase Ib/II: Tmax [Time frame: Up to approximately 24 months]
• Phase Ib: T1/2 [Time frame: Up to approximately 24 months]
• Phase Ib: AUC0-t [Time frame: Up to approximately 24 months]
• Phase Ib: CL [Time frame: Up to approximately 24 months]
• Phase Ib/II: Ctrough [Time frame: Up to approximately 24 months]
• Phase Ib/II: Anti-drug antibody (ADA) [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• Albumin ≥30 g/L;
• For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends.

Exclusion criteria

• Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;
• Previously treated with ADC drugs containing camptothecin derivatives as payloads;
• History of severe cardiovascular or cerebrovascular diseases;
• Active autoimmune or inflammatory diseases;
• History of other malignancies within 5 years prior to the first dose;
• Thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;
• Poorly controlled hypertension despite antihypertensive medication;
• Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;
• Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;
• History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;
• Active hepatitis B virus (HBV) infection (exclusion criterion);
• Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;
• Participation in another clinical trial within 4 weeks before the first dose;
• Pregnant or lactating women;
• Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06031584 · BL-M07D1-202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗