Clinical trial NCT05957471: Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors
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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors
Keywords: Solid Tumors
Lead sponsor: Biocity Biopharmaceutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs) .
timeFrame: Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: