Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06505824

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors

Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-18

22

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

S

Sichuan Baili Pharmaceutical Co., Ltd.

Lead Sponsor

B

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors.

CONDITIONS

Official Title

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent and follow protocol requirements
  • No gender restriction
  • Age 18 to 75 years for Phase Ia; age 18 years and older for Phase Ib
  • Expected survival time of at least 3 months
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are incurable or have no standard treatment
  • Consent to provide archival or fresh tumor tissue samples from primary or metastatic lesions within 2 years
  • At least one measurable lesion according to RECIST v1.1
  • ECOG performance status 0 or 1
  • Toxicity from prior cancer therapy has resolved to grade 1 or less
  • No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
  • Organ function meets study requirements without recent blood transfusion or growth factor drugs
  • Coagulation function: INR 1.5 or less and APTT 1.5 times the upper limit of normal or less
  • Urine protein level +2 or 1000 mg/24 h or less
  • Premenopausal women must have a negative pregnancy test and not be breastfeeding; all patients advised to use barrier contraception during treatment and for 6 months after
Not Eligible

You will not qualify if you...

  • Anti-tumor therapy within 4 weeks or 5 half-lives before first dose; mitomycin or nitrosoureas within 6 weeks; oral fluorouracil
  • Prior antibody-drug conjugate with TOPI inhibitor toxin
  • History of severe heart or cerebrovascular disease
  • QT prolongation, complete left bundle branch block, third-degree AV block, or uncontrolled arrhythmia
  • Active autoimmune or inflammatory diseases
  • Other cancers diagnosed within 5 years before first dose
  • Poorly controlled hypertension despite two drugs
  • History or current interstitial lung disease or grade 2 or higher radiation pneumonitis
  • Severe pulmonary diseases causing respiratory impairment
  • Massive or symptomatic pleural effusions
  • Tumor invasion or encasement of major chest, neck, or pharynx vessels
  • Unstable thrombotic events within 6 months
  • Active central nervous system metastases
  • Allergy to humanized or chimeric antibodies or BL-M14D1 components
  • Prior organ or stem cell transplant
  • High cumulative anthracycline dose over 360 mg/m2
  • HIV positive or active tuberculosis or hepatitis B or C infection
  • Active infections requiring systemic therapy within 4 weeks
  • Recent participation in another clinical trial within 4 weeks
  • Pregnant or breastfeeding women
  • Severe neurological or psychiatric illness
  • Severe wounds, ulcers, or fractures within 4 weeks
  • Significant bleeding or bleeding disorders within 4 weeks
  • History of intestinal obstruction, inflammatory bowel disease, extensive bowel surgery, Crohn's disease, ulcerative colitis, or chronic diarrhea
  • Planned vaccination or live vaccine within 28 days before first dose
  • Other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

Loading map...

Research Team

S

Sa Xiao, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here