Study of BC3195 Monotherapy in Patients With Advanced Sol... | NCT05957471

Studies
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors

NCT05957471

Sponsor

Biocity Biopharmaceutics Co., Ltd.

Status

Unknown status

Last Update Posted

Jul 24, 2023Actual

Enrollment

27Estimated

Phase

Phase 1

Conditions

Locally Advanced or Metastatic Solid Tumors

Interventions

Drug: BC3195 for Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2023Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Jul 13, 2023

First Submission Date that Met QC Criteria

Jul 20, 2023

First Posted Date

Jul 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2023

Last Update Posted Date

Jul 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.

Detailed Description

This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.

The patients in whom standard treatment has failed (either due to disease progression or intolerance), who meet the criteria will receive BC3195 via intravenous (IV) in 21-day treatment cycles.

A Safety Monitoring Committee (SMC) will be established to decide the dose levels to be administered and dose regimen during dose escalation based on a thorough review of all the safety, PK (if applicable), and other relevant data from the previous dose cohort, and to determine the MTD and the putative RP2D for dose expansion.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BC3195 treatment group.	Experimental	BC3195 via intravenous(IV).	Drug: Drug: BC3195 for Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug: BC3195 for Injection	Drug	BC3195 via intravenous(IV).	BC3195 treatment group.

Measure	Description	Time Frame
Incidence of dose limiting toxicities (DLTs) .		Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients voluntarily participate in the study and should provide a written informed consent.
Male or female patients ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Subjects with locally advanced or metastatic solid tumors failed to prior SOCs and no appropriate SOC to treat the current disease per investigator's judgement.
Life expectancy ≥ 3 months.
Subjects with adequate organ function.
Men or women of childbearing potential (which refer to men or women who have not been surgically sterilized and pre-menopausal women) must use a highly effective method of contraception during the study and continue to take contraception measures for 6 months after the last dose of the study drug.

Exclusion Criteria:

Pregnant or lactating women.
Prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter).
Active viral infection requiring systemic therapy during the screening period.
Hypertension that cannot be well-controlled with medical treatment.
Cardiovascular disease of clinical significance.
Subjects with any active infection that requires anti-infective therapy judged by the investigators.
Subjects are not suitable for participating the study judged by the investigators.
Subjects with poor compliance, who are unwilling to or unable to follow study procedures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yilong Wu	Contact	021-38804518	22132	syylwu@live.cn
Huajun Chen	Contact	021-38804518	22132	chenhuajun@gdph.org.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Provincial People's Hospital	Recruiting	Guangzhou	Guangdong	510060	China

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics