A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors

NCT07841925 | Not Yet Recruiting Phase 1

• 1 other identifier: BL-M08D1-207
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase Ib/II study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic melanoma and other solid tumors.

Conditions

Melanoma; Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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-M08D1.

  Up to approximately 24 months

• 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 (11)

• Progression-free Survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (1)

BL-M08D1

EXPERIMENTAL

Participants receive BL-M08D1 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-M08D1

Interventions

BL-M08D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M08D1

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 protocol requirements;
• No restriction on gender;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Locally advanced or metastatic melanoma and other solid tumors;
• Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1, with no deterioration within 2 weeks before the first dose;
• Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, 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;
• Urine protein ≤1+ or ≤1000 mg/24 h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must be non-lactating; all enrolled patients (whether male or female) should use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment ends;
• 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:

• Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose;
• History of severe heart disease or cerebrovascular disease;
• QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of 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 antihypertensive drugs;
• Patients with poorly controlled blood glucose;
• History of interstitial lung disease requiring hormone therapy, or current ILD or grade \>= 2 radiation pneumonitis;
• Severe impairment of respiratory function;
• Active central nervous system metastasis;
• Previous or concomitant central nervous system lesions;
• Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M08D1;
• 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;

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

+86 15013238943; 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 20, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

CN (1)