CClinicalTrials.gg
Sign In
Not yet recruitingNCT07841925Updated Sep 25, 2026

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

A Phase 1/2 interventional study of BL-M08D1 in Melanoma and Solid Tumors, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Sichuan Baili Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Melanoma
  • Solid Tumors

Browse trials for

03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily sign the informed consent form and comply with protocol requirements;
  2. No restriction on gender;
  3. Age: ≥18 years and ≤75 years;
  4. Expected survival time ≥3 months;
  5. Locally advanced or metastatic melanoma and other solid tumors;
  6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples;
  7. Must have at least one measurable lesion as defined by RECIST v1.1;
  8. ECOG performance status score of 0 or 1, with no deterioration within 2 weeks before the first dose;
  9. Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;
  10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  11. Organ function levels must meet the requirements;
  12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN;
  13. Urine protein ≤1+ or ≤1000 mg/24 h;
  14. 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;
  15. 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.

Exclusion criteria

Exclusion Criteria:

  1. Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose;
  2. History of severe heart disease or cerebrovascular disease;
  3. QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
  4. Active autoimmune diseases and inflammatory diseases;
  5. Diagnosis of other malignancies within 5 years before the first dose;
  6. Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;
  7. Hypertension poorly controlled by antihypertensive drugs;
  8. Patients with poorly controlled blood glucose;
  9. History of interstitial lung disease requiring hormone therapy, or current ILD or grade >= 2 radiation pneumonitis;
  10. Severe impairment of respiratory function;
  11. Active central nervous system metastasis;
  12. Previous or concomitant central nervous system lesions;
  13. Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M08D1;
  14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
  15. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
  16. Presence of active infection requiring systemic treatment within 4 weeks before the first study drug administration;
  17. Presence of pleural, abdominal, pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks before the first study drug administration;
  18. Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, neck, etc.;
  19. Use of another clinical trial drug within 4 weeks or 5 half-lives before the first dose;
  20. Pregnant or breastfeeding women;
  21. Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    BL-M08D1

    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

  • DrugBL-M08D1

    Administration by intravenous infusion for a cycle of 3 weeks.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 24 months

  2. 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.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Time frame: Up to approximately 24 months

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Time frame: Up to approximately 24 months

  3. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Time frame: Up to approximately 24 months

  4. 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-M08D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M08D1.

    Time frame: Up to approximately 24 months

  5. Cmax

    Cmax is defined as the maximum observed drug concentration in plasma after administration.

    Time frame: Up to approximately 24 months

  6. Tmax

    Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.

    Time frame: Up to approximately 24 months

  7. T1/2

    T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.

    Time frame: Up to approximately 24 months

  8. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Time frame: Up to approximately 24 months

  9. CL (Clearance)

    Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.

    Time frame: Up to approximately 24 months

  10. Ctrough

    Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.

    Time frame: Up to approximately 24 months

  11. Anti-drug Antibody (ADA)

    Frequency of anti-BL-M08D1 antibody (ADA) will be investigated.

    Time frame: Up to approximately 24 months

06

Study locations

1 site
  • Beijing Cancer Hospital
    Beijing, Beijing Municipality, China
    • Jun Guo · Contact
07

Registry details

Key details

Study ID
NCT07841925
Lead sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Sa Xiao, PHD
Contact
xiaosa@baili-pharm.com
+86 15013238943

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Melanoma→

Other studies from this sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Start the discussion