This study is an open, multicenter, dose-escalation and expanded-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
Voluntarily sign the informed consent and follow the requirements of the protocol;
No gender limit;
Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
Expected survival time ≥3 months;
Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
History of severe heart disease;
QT prolongation, complete left bundle branch block, III degree atrioventricular block;
Active autoimmune and inflammatory diseases;
Single group
BL-M09D1
DrugAdministration by intravenous infusion for a cycle of 3 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-M09D1.
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-M09D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M09D1.
Cmax
Maximum serum concentration (Cmax) of BL-M09D1 will be investigated.
Tmax
Time to maximum serum concentration (Tmax) of BL-M09D1 will be investigated.
T1/2
Half-life (T1/2) of BL-M09D1 will be investigated.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
