Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

BL-M07D1

Hai Zhu, PHD

Sa Xiao, PHD

WeiJian Guo, PHD

Jian Zhang, PHD

WeiJian Guo

Jian Zhang

Weijian Guo, PHD

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.

Phase Ia: To observe the safety and tolerability of BL-M07D1 in patients with locally advanced or metastatic digestive tract tumors and other solid tumors, determine the MTD and DLT of BL-M07D1, and evaluate the pharmacokinetic characteristics and immunogenicity of BL-M07D1. Phase Ib: To further observe the safety and tolerability of BL-M07D1 at the Phase Ia recommended dose and determine RP2D. To evaluate the initial efficacy, pharmacokinetic characteristics and immunogenicity of BL-M07D1.

Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Initial Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

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).

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.

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.

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 .

Maximum serum concentration (Cmax) of BL-M07D1 will be investigated.

Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated.

Half-life (T1/2) of BL-M07D1 will be investigated.

AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

To study the serum clearance rate of BL-M07D1 per unit time.

Ctough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.

Frequency and titer of anti-BL-M07D1 antibody (ADA) will be evaluated.

ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

The PFS is defined as the time from the participant's first dose of BL-B07D1 to the first date of either disease progression or death, whichever occurs first.

The time between the start of study medication and death.

SystImmune Inc.

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Sichuan Baili Pharmaceutical Co., Ltd.

Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Participants receive BL-M02D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

BL-M02D1

Ruihua Xu

Ruihua Xu, PHD

In phase Ia study, the safety and tolerability of BL-M02D1 in patients with locally advanced or metastatic gastroenteric tumor or other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M02D1.

In phase Ib study, the safety and tolerability of BL-M02D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M02D1 in patients with locally advanced or metastatic gastroenteric tumor or other solid tumors will be evaluated.

A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors or Other Solid Tumors

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Injectable BL-M02D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors or Other Solid Tumors

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.

MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

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-M02D1.

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-M02D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M02D1.

Maximum serum concentration (Cmax) of BL-M02D1 will be investigated.

Time to maximum serum concentration (Tmax) of BL-M02D1 will be investigated.

CL in the serum of BL-M02D1 per unit of time will be investigated.

Ctough is defined as the lowest serum concentration of BL-M02D1 prior to the next dose will be administered.

Incidence and titer of ADA of BL-M02D1 will be evaluated.

Incidence and titer of Nab of BL-M02D1 will be evaluated.

The PFS is defined as the time from the participant's first dose of BL-M02D1 to the first date of either disease progression or death, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors	NCT05631964	Locally Advance... Other Solid Tum...	BL-M07D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors or Other Solid Tumors	NCT05385692	Locally Advance... Solid Tumor	BL-M02D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors or Other Solid Tumors	NCT05385692	Locally Advance... Solid Tumor	BL-M02D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors	NCT05631964	Locally Advance... Other Solid Tum...	BL-M07D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for locally advanced or metastatic digestive tract tumors