Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors

Locally Advanced or Metastatic Solid Tumors Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957471
• Other study ID #: BC3195-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 26, 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: Biocity Biopharmaceutics Co., Ltd.
• Contact: Yilong Wu
• Phone: 021-38804518
• Email: syylwu[@]live.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• Drug: BC3195 for Injection
BC3195 via intravenous(IV).

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Biocity Biopharmaceutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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