A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.
About this trial
This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restrictions;
Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
Expected survival time ≥3 months;
Disqualifiers
Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
History of serious heart 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 groupLocations
1Tianjin Cancer Hospital TianjinTianjin Municipality, China
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov