A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-ARC002 Injection in patients with locally advanced or metastatic solid tumors.

Eligibility criteria

Qualifiers

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

No gender restriction;

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

Expected survival ≥3 months;

Disqualifiers

Use of chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;

History of severe cardiac disease;

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

Active autoimmune diseases and inflammatory diseases;

Trial design

Treatments tested in this trial

  • BL-ARC002

Treatment groups

22 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

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

Collaborator