BC3195 treatment for advanced solid tumors

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

This study is testing a new treatment called BC3195 for people with advanced solid tumors that haven't responded to other therapies to see if it is safe and effective.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biocity Biopharmaceutics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05957471 on ClinicalTrials.gov

What this trial studies

This phase I study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of BC3195 in patients with locally advanced or metastatic solid tumors. Participants who have not responded to standard treatments will receive BC3195 via intravenous administration in 21-day treatment cycles. A Safety Monitoring Committee will oversee dose levels and regimens during the dose escalation phase to determine the maximum tolerated dose and the recommended phase 2 dose for further evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic solid tumors that have failed prior standard of care treatments.

Not a fit: Patients who are pregnant, lactating, or have active viral infections requiring systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in evaluating new therapies.

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Yilong Wu

Conditions Locally Advanced or Metastatic Solid Tumors; Solid Tumors