CClinicalTrials.gg
Sign In
RecruitingNCT07232420Updated Nov 24, 2025

A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors

A Phase 1 interventional study of BL-M24D1 in Non Small Cell Lung Cancer and Solid Tumor, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

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

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M24D1 in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.

Read the detailed description

The study consists of two phases: a dose escalation phase (Phase Ia) and a dose expansion phase (Phase Ib).

02

Conditions studied

  • Non Small Cell Lung Cancer
  • Solid Tumor
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 33 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Sichuan Baili Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily sign the informed consent form and comply with the protocol requirements;
  2. Gender unrestricted;
  3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
  4. Expected survival time ≥3 months;
  5. Locally advanced or metastatic non-small cell lung cancer and other solid tumors;
  6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;
  7. Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
  8. ECOG performance status score of 0 or 1;
  9. Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
  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 ≤2+ or ≤1000mg/24h;
  14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.

Exclusion criteria

Exclusion Criteria:

  1. Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives prior to the first dose;
  2. History of severe heart disease;
  3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
  4. Active autoimmune or inflammatory diseases;
  5. Diagnosis of other malignancies within 5 years prior to the first dose;
  6. Hypertension poorly controlled by two antihypertensive medications;
  7. Poorly controlled blood glucose;
  8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
  9. Lung diseases graded ≥3 according to CTCAE v5.0;
  10. Symptoms of active central nervous system metastasis;
  11. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M24D1;
  12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
  13. Cumulative dose of anthracyclines >360 mg/m² in previous (neo)adjuvant anthracycline therapy;
  14. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
  15. History of interstitial lung disease requiring hormonal treatment, or current ILD;
  16. Active infection requiring systemic treatment within 4 weeks prior to the first investigational drug dose;
  17. Pleural, peritoneal, pelvic, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first investigational drug dose;
  18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first investigational drug dose;
  19. Participation in another clinical trial within 4 weeks prior to the first dose;
  20. Pregnant or lactating women;
  21. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
05

Study design

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

Study arms

  • Experimental
    BL-M24D1

    Participants receive BL-M24D1 as intravenous infusion for the first cycle (2 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-M24D1

Interventions

  • DrugBL-M24D1

    Administration by intravenous infusion for a cycle of 2 weeks.

06

What researchers measure

Primary outcomes

  1. Phase Ia: Dose limiting toxicity (DLT)

    DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

    Time frame: Up to 28 days after the first dose

  2. Phase Ia: Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

    Time frame: Up to 28 days after the first dose

  3. 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 of BL-M24D1.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. 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-M24D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M24D1.

    Time frame: Up to approximately 24 months

  2. Cmax

    Maximum serum concentration (Cmax) of BL-M24D1 will be investigated.

    Time frame: Up to approximately 24 months

  3. Tmax

    Time to maximum serum concentration (Tmax) of BL-M24D1 will be investigated.

    Time frame: Up to approximately 24 months

  4. T1/2

    Half-life (T1/2) of BL-M24D1 will be investigated.

    Time frame: Up to approximately 24 months

  5. 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

  6. CL (Clearance)

    CL in the serum of BL-M24D1 per unit of time will be investigated.

    Time frame: Up to approximately 24 months

  7. Ctrough

    Ctrough is defined as the lowest serum concentration of BL-M24D1 prior to the next dose will be administered.

    Time frame: Up to approximately 24 months

  8. ADA (anti-drug antibody)

    Frequency of anti-BL-M24D1 antibody (ADA) will be investigated.

    Time frame: Up to approximately 24 months

  9. Phase Ib: 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

  10. Phase Ib: Disease Control Rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

    Time frame: Up to approximately 24 months

  11. Phase Ib: Duration of Response (DOR)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Time frame: Up to approximately 24 months

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong, China
    • Li Zhang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07232420
Lead sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 18, 2025
Start date
Nov 11, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 24, 2025

Study contacts

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

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

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

Carcinoma, Non-Small-Cell Lung→

Other studies from this sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Start the discussion