A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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 for Injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent form and comply with the protocol requirements;

No gender restrictions;

Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);

Expected survival time ≥3 months;

Disqualifiers

Use of chemotherapy, biological therapy, or immunotherapy within 4 weeks prior to the first dose or within 5 half-lives;

History of severe heart disease;

QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;

Active autoimmune or inflammatory diseases;

Trial design

Treatments tested in this trial

  • BL-M24D1

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

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

Collaborator