Trials Sponsors Conditions Drugs Pricing

Conditions

Gynecological Tumors Solid Tumors

Outcome Measures

Primary Outcomes (3)

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
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
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 SI-B036.
Up to approximately 24 months

Secondary Outcomes (12)

Treatment-Emergent Adverse Event (TEAE)
Up to approximately 24 months
Cmax
Up to approximately 24 months
Tmax
Up to approximately 24 months
T1/2
Up to approximately 24 months
AUC0-t
Up to approximately 24 months
+7 more secondary outcomes

Study Arms (1)

SI-B036

EXPERIMENTAL

Participants receive SI-B036 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.

Drug: SI-B036

Interventions

SI-B036Drug

Administration by intravenous infusion for a cycle of 3 weeks.

SI-B036

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restriction;

Sponsors & Collaborators

Sichuan Baili Pharmaceutical Co., Ltd.
Industrylead
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Industrycollaborator

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Qinglei GaoCONTACT

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943 xiaosa@baili-pharm.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 21, 2026

Study Start

September 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2028

Estimated

A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gynecological Tumors and Other Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (12)

Study Arms (1)

SI-B036

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (12)

Study Arms (1)

SI-B036

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations