This study is an open-label, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of Lutetium \[177Lu\] BL-ARC001 in patients with locally advanced or metastatic solid tumors.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Gender: no restriction;
Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
Expected survival time ≥3 months;
Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose;
History of severe heart disease;
QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
Active autoimmune or inflammatory diseases;
Single group
Lutetium [177Lu] BL-ARC001
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 Lutetium \[177Lu\] BL-ARC001.
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 Lutetium \[177Lu\] BL-ARC001. The type, frequency and severity of TEAE will be evaluated during the treatment of Lutetium \[177Lu\] BL-ARC001.
Cmax
Maximum serum concentration (Cmax) of Lutetium \[177Lu\] BL-ARC001 will be investigated.
Tmax
Time to maximum serum concentration (Tmax) of Lutetium \[177Lu\] BL-ARC001 will be investigated.
T1/2
Half-life (T1/2) of Lutetium \[177Lu\] BL-ARC001 will be investigated.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
