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Trial Title:
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors
NCT ID:
NCT05957471
Condition:
Locally Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Drug: BC3195 for Injection
Description:
BC3195 via intravenous(IV).
Arm group label:
BC3195 treatment group.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yilong Wu
Phone:
021-38804518
Phone ext:
22132
Email:
syylwu@live.cn
Contact backup:
Last name:
Huajun Chen
Phone:
021-38804518
Phone ext:
22132
Email:
chenhuajun@gdph.org.cn
Start date:
June 26, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Biocity Biopharmaceutics Co., Ltd.
Agency class:
Industry
Source:
Biocity Biopharmaceutics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957471
