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.
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;
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;
Single group
BL-ARC002
DrugAdministration by intravenous infusion for a cycle of 6 weeks.
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.
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.
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-ARC002.
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-ARC002. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-ARC002.
Cmax
Cmax is defined as the maximum observed drug concentration in plasma after administration.
Tmax
Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.
T1/2
T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
