Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors

NCT05957471 | Unknown Phase 1

• 1 other identifier: BC3195-101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities (DLTs) .

  Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).

Study Arms (1)

BC3195 treatment group.

EXPERIMENTAL

BC3195 via intravenous(IV).

Drug: Drug: BC3195 for Injection

Interventions

Drug: BC3195 for Injection DRUG

BC3195 via intravenous(IV).

BC3195 treatment group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yilong Wu

CONTACT

021-38804518; syylwu@live.cn

Huajun Chen

CONTACT

021-38804518; chenhuajun@gdph.org.cn

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: July 13, 2023
• First Posted: July 24, 2023
• Study Start: June 26, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

CN (1)