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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05262491
Other study ID # BL-B01D1-103
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 14, 2022
Est. completion date August 2024

Study information

Verified date April 2024
Source Sichuan Baili Pharmaceutical Co., Ltd.
Contact Hai Zhu, PHD
Phone +8613980051002
Email zhuhai@baili-pharm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 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-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated.


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Study Design


Intervention

Drug:
BL-B01D1
Administration by intravenous infusion

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China West China Hospital, Sichuan University Chengdu Sichuan
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Jinan Central Hospital Jinan Shandong
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Tianjin Medical University General Hospital Tianjin Tianjin

Sponsors (3)

Lead Sponsor Collaborator
Sichuan Baili Pharmaceutical Co., Ltd. Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., SystImmune Inc.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 21 days after the first dose
Primary 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 . Up to 21 days after the first dose
Primary 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-B01D1 Up to 21 days after the first dose
Secondary 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-B01D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1 . Up to approximately 24 months
Secondary Cmax Maximum serum concentration (Cmax) of BL-B01D1 will be investigated. Up to 21 days after the first dose
Secondary Tmax Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated Up to 21 days after the first dose
Secondary T1/2 Half-life (T1/2) of BL-B01D1 will be investigated Up to 21 days after the first dose
Secondary AUC0-t AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration. Up to 21 days after the first dose
Secondary CL (Clearance) CL in the serum of BL-B01D1 per unit of time will be investigated Up to 21 days after the first dose
Secondary Ctrough Ctough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered Up to 21 days after the first dose
Secondary ADA (anti-drug antibody) Incidence and titer of ADA of BL-B01D1 will be evaluated Up to approximately 24 months
Secondary Nab (neutralizing antibody) Incidence and titer of Nab of BL-B01D1 will be evaluated. Up to approximately 24 months
Secondary Objective Response Rate (ORR) 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. Up to approximately 24 months
Secondary Disease Control Rate (DCR) 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]). Up to approximately 24 months
Secondary Duration of Response (DOR) 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. Up to approximately 24 months
Secondary Progression-free Survival (PFS) The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first. Up to approximately 24 months
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