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Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors (BC3195)

Primary Purpose

Locally Advanced or Metastatic Solid Tumors

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Drug: BC3195 for Injection
Sponsored by
Biocity Biopharmaceutics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced or Metastatic Solid Tumors focused on measuring Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BC3195 treatment group.

Arm Description

BC3195 via intravenous(IV).

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities (DLTs) .

Secondary Outcome Measures

Full Information

First Posted
July 13, 2023
Last Updated
July 20, 2023
Sponsor
Biocity Biopharmaceutics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05957471
Brief Title
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors
Acronym
BC3195
Official Title
A Phase Ia/Ib, Open-Label, First-in-human, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocity Biopharmaceutics Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Solid Tumors
Keywords
Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BC3195 treatment group.
Arm Type
Experimental
Arm Description
BC3195 via intravenous(IV).
Intervention Type
Drug
Intervention Name(s)
Drug: BC3195 for Injection
Intervention Description
BC3195 via intravenous(IV).
Primary Outcome Measure Information:
Title
Incidence of dose limiting toxicities (DLTs) .
Time Frame
Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yilong Wu
Phone
021-38804518
Ext
22132
Email
syylwu@live.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huajun Chen
Phone
021-38804518
Ext
22132
Email
chenhuajun@gdph.org.cn
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yilong Wu
Phone
021-38804518
Ext
22132
Email
syylwu@live.cn
First Name & Middle Initial & Last Name & Degree
Huajun Chen
Phone
021-38804518
Ext
22132
Email
chenhuajun@gdph.org.cn

12. IPD Sharing Statement

Learn more about this trial

Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors

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