Evaluation of BL-M07D1 for injection in Phase I clinical study of safety, tolerability, pharmacokinetic Characteristics, and initial efficacy in patients with locally advanced or metastatic digestive tract tumors and other solid tumors.
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No gender limitation.
Age: ≥18 years and ≤75 years (phase Ia); ≥18 years old (phase Ib).
The expected survival time is ≥3 months.
Antitumor therapy such as chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small-molecule tyrosine kinase inhibitors) within 4 weeks prior to initial administration or within 5 half-lives, whichever is shorter; Mitomycin and nitrosourea were administered within 6 weeks before the first administration. Oral fluorouracil drugs such as Tizio, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration; Traditional Chinese medicines or proprietary Chinese medicines with anti-tumor indications should be administered within 2 weeks before the first administration.
Previously received ADC drug therapy with camptothecin derivatives (topoisomerase I inhibitors) as toxins (Phase Ib only).
History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥2 (CTCAE 5.0), New York Heart Society (NYHA) ≥2 heart failure, history of transmural myocardial infarction, unstable angina, etc.
Prolonged QT interval (QTcF > 450 msec in men or 470 msec in women), complete left bundle branch block, and degree III atrioventricular block.
Single group
BL-M07D1
DrugAdministration by intravenous infusion
Phase Ia: Dose Limited Toxicity (DLT)
The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).
Phase Ia: Maximum Tolerated Dose (MTD)
In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Phase Ib: Recommended Dose for Phase II Clinical Studies (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-M07D1.
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-B07D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1 .
Cmax
Maximum serum concentration (Cmax) of BL-M07D1 will be investigated.
Tmax
Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated.
T1/2
Half-life (T1/2) of BL-M07D1 will be investigated.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
SystImmune Inc.
Collaborator
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
