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

NCT06031584 | Recruiting Phase 1

• 1 other identifier: BL-M07D1-202
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Her2-positive/Low-expression Urinary and Digestive Tract Tumors

Outcome Measures

Primary Outcomes (2)

• Phase Ib: Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study.

  Up to approximately 24 months

• Phase II: Objective response rate (ORR)

  ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

  Up to approximately 24 months

Secondary Outcomes (12)

• Phase Ib/II: Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Phase Ib: Objective response rate (ORR)

  Up to approximately 24 months

• Phase Ib/II: Disease control rate (DCR)

  Up to approximately 24 months

• Phase Ib/II: Duration of response (DOR)

  Up to approximately 24 months

• Phase II: Progression-free survival (PFS)

  Up to approximately 24 months

Study Arms (1)

Study treatment

EXPERIMENTAL

Participants received BL-M07D1 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.

Drug: BL-M07D1

Interventions

BL-M07D1 DRUG

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

Study treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Aiping Zhou, PHD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)