A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors

NCT07837622 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-M09D1-202
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, open-label, multicenter, non-randomized phase IIa/IIb clinical study to evaluate the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors.

Conditions

Urothelial Carcinoma (UC); Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Phase IIa: 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 of BL-M09D1.

  Up to approximately 24 months

• Phase IIa: Treatment-Emergent Adverse Event (TEAE)

  TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M09D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M09D1.

  Up to approximately 24 months

• Phase IIb: Objective Response Rate (ORR)

  Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

  Up to approximately 24 months

Secondary Outcomes (10)

• Phase IIa: Objective Response Rate (ORR)

  Up to approximately 24 months

• Phase IIa/IIb: Progression-free Survival (PFS)

  Up to approximately 24 months

• Phase IIa/IIb: Disease Control Rate (DCR)

  Up to approximately 24 months

• Phase IIa/IIb: Duration of Response (DOR)

  Up to approximately 24 months

• Phase IIb: Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

BL-M09D1

EXPERIMENTAL

Participants receive BL-M09D1 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-M09D1

Interventions

BL-M09D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M09D1

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;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Locally advanced or metastatic urothelial carcinoma and other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesion within 2 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN;
• For premenopausal female trial participants of childbearing potential, a serum pregnancy test must be performed within 7 days before the start of treatment. The serum pregnancy test must exclude pregnancy, and the participant must not be breastfeeding; all enrolled trial participants and their partners must agree to use adequate highly effective contraceptive measures throughout the entire treatment period and for 7 months (women) and 4 months (men) after the end of treatment. It is recommended to also use other contraceptive methods, such as barrier contraception;
• Trial participants are able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.

You may not qualify if:

• Received chemotherapy, targeted therapy, biological therapy, etc. within 4 weeks or 5 half-lives before the first dose;
• History of severe heart disease;
• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block; frequent and uncontrollable arrhythmias;
• Active autoimmune disease or inflammatory disease;
• Diagnosed with other malignancies within 5 years before the first dose;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;
• Hypertension poorly controlled by two antihypertensive drugs;
• Patients with poorly controlled blood glucose;
• History of interstitial lung disease requiring hormone therapy, or current ILD or grade \>= 2 radiation pneumonitis;
• Concurrent lung disease causing clinically severe impairment of respiratory function;
• Active central nervous system metastasis;
• Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M09D1;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Active infection requiring systemic treatment within 4 weeks before the first study drug administration;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Sa Xiao, PHD

CONTACT

+86 15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)