Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors

NCT ID: NCT05957471

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2025-06-30

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BC3195 treatment group.

BC3195 via intravenous(IV).

Group Type: EXPERIMENTAL

Drug: BC3195 for Injection

Intervention Type: DRUG

BC3195 via intravenous(IV).

Interventions

Drug: BC3195 for Injection

BC3195 via intravenous(IV).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients voluntarily participate in the study and should provide a written informed consent.

2. Male or female patients ≥ 18 years of age.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

4. 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.

5. Life expectancy ≥ 3 months.

6. Subjects with adequate organ function.

7. 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

1. Pregnant or lactating women.

2. Prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter).

3. Active viral infection requiring systemic therapy during the screening period.

4. Hypertension that cannot be well-controlled with medical treatment.

5. Cardiovascular disease of clinical significance.

6. Subjects with any active infection that requires anti-infective therapy judged by the investigators.

7. Subjects are not suitable for participating the study judged by the investigators.

8. Subjects with poor compliance, who are unwilling to or unable to follow study procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocity Biopharmaceutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yilong Wu

Role: CONTACT

syylwu@live.cn

021-38804518 ext. 22132

Huajun Chen

Role: CONTACT

chenhuajun@gdph.org.cn

021-38804518 ext. 22132

Facility Contacts

Yilong Wu

Role: primary

syylwu@live.cn

021-38804518 ext. 22132

Huajun Chen

Role: backup

chenhuajun@gdph.org.cn

021-38804518 ext. 22132

Other Identifiers

BC3195-101

Identifier Type: -

Identifier Source: org_study_id