Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Kidney Neoplasms

Renal Cell Carcinoma

Participants receive BL-B01D1 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-B01D1

Hai Zhu, PHD

Sa Xiao, PHD

Jun Guo, PHD

Zhisong He

Nan Liu

Jiyan Liu

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic urinary tumors and other solid tumors 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 urinary tumors and other solid tumors will be evaluated.

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and 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-B01D1

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 .

Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.

Half-life (T1/2) of BL-B01D1 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.

CL in the serum of BL-B01D1 per unit of time will be investigated.

Ctough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.

Incidence and titer of ADA of BL-B01D1 will be evaluated.

Incidence and titer of Nab of BL-B01D1 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-B01D1 to the first date of either disease progression or death, whichever occurs first.

The OS is defined as the time from randomization to death (from any cause).

SystImmune Inc.

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

Sichuan Baili Pharmaceutical Co., Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Triple Negative Breast Neoplasms

Melanoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Participants receive SI-B003 as intravenous infusion for the first cycle (4 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.

SI-B003

Hai Zhu

Sa Xiao

Lin Shen

Jifang Gong

Yongsheng Li

Wang Sheng

Suxia Luo

Shan An

Yi Huang

Guiling Li

Qi Li

Haiyan Zhang

In phase Ia study, the safety and tolerability of SI-B003 in patients with recurrent or metastatic solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of SI-B003.

In the phase Ib study, the safety and tolerability of SI-B003 in specific tumors will be further investigated by selecting multiple doses based on the results of phase Ia study or/and the fixed-dose administration method with the closest exposure level, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

DLTs is assessed according to NCI-CTCAE v5.0 during the first cycle (28 days) and were defined as occurrence of any of the following toxicities if judged by the investigator to be possibly, probably or definitely related to study drug administration.

MTD is defined as the dose with the estimated DLT rate closest to the target DLT rate (33%) is selected as the MTD.

If there are two or more estimated values close to the target DLT rate and the same, when the estimated value is lower than the target DLT rate, choose the higher dose, and when the estimated value is greater than or equal to the target toxicity rate, choose a lower dose.

MAD is defined as the maximum administered dose, when MTD is not reached.

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 SI-B003. The type, frequency and severity of TEAE will be evaluated during the treatment of SI-B003.

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B003.

Maximum serum concentration (Cmax) of SI-B003 will be investigated.

Time to maximum serum concentration (Tmax) of SI-B003 will be investigated.

Half-life (T1/2) of SI-B003 will be investigated.

Clearance (CL) in the serum of SI-B003 per unit of time will be investigated.

Ctrough is defined as the lowest serum concentration of SI-B003 prior to the next dose will be administered.

AESI is defined as AE that may not be serious but have special meaning or importance for SI-B003.

Incidence and titer of ADA of SI-B003 will be evaluated.

Incidence and titer of NAb of SI-B003 will be evaluated.

ORR was defined as the percentage of participants, who had a CR or PR. The percentage of participants who experienced a confirmed CR or PR is evaluated by investigator and third-party independent medical imaging agency according to RECIST 1.1.

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 DOR is evaluated by investigator and third-party independent medical imaging agency according to RECIST 1.1.

CBR was defined as the percentage of participants, who had a CR, PR or SD. The percentage of participants who experienced a confirmed CR, PR or SD is evaluated by investigator and third-party independent medical imaging agency according to RECIST 1.1.

The PFS is defined as the time from the participant's first dose of SI-B003 to the first date of either disease progression or death, whichever occurs first. 6 and 12 months PFS will be evaluated by investigator and third-party independent medical imaging agency according to RECIST 1.1.

12 months OS will be evaluated by investigator and third-party independent medical imaging agency according to RECIST 1.1.

The correlation of PK parameters (Cmax, AUC0-t, Ctrough, etc.) and clinical efficacy indexes (ORR, CBR, PFS, etc.) will be evaluated.

iORR will be evaluated by investigator and third-party independent medical imaging agency according to iRECIST 1.1.

iCR will be evaluated by investigator and third-party independent medical imaging agency according to iRECIST 1.1.

iPR will be evaluated by investigator and third-party independent medical imaging agency according to iRECIST 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors	NCT05393427	Locally Advance... Other Solid Tum...	BL-B01D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors	NCT04606472	Solid Tumor	SI-B003	18 Years -	Sichuan Baili Pharmaceutical Co., Ltd.
A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors	NCT04606472	Solid Tumor	SI-B003	18 Years -	Sichuan Baili Pharmaceutical Co., Ltd.
A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors	NCT04606472	Solid Tumor	SI-B003	18 Years -	Sichuan Baili Pharmaceutical Co., Ltd.
A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors	NCT04606472	Solid Tumor	SI-B003	18 Years -	Sichuan Baili Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for urothelial cancer (uc)