NCT07368478

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies

A Phase Ⅰa/Ⅰb, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Biocity Biopharmaceutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ia/Ib, open-label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, and preliminary anticancer activity of BC2027 in patients with advanced solid Malignanciesr

Detailed description

This is a phase Ia/Ib, open-label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, and preliminary anticancer activity of BC2027 in patients with advanced solid Malignanciesr. This study will consist of two parts: Part 1, a dose escalation part (Phase Ia) and Part 2, a dose expansion part (Phase Ib). Both parts will include a screening period (within 28 days prior to dosing), a treatment period (Q2W(28-day cycle), Q3W(21-day cycle)), a safety follow-up period (45 days (±5 days) after last dose), and a survival follow-up period (every 12 weeks until death)

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	BC2027 for Injection	Drug: BC2027 for Injection (lyophilized powder, 20 mg/vial) Administration: Administered via intravenous (IV) infusion, with dosing and frequency determined according to Phase Ia (dose escalation) and Phase Ib (dose expansion) study design.

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: China