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

NCT07368478 | Recruiting Phase 1

• 1 other identifier: BC2027-102
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Solid Malignancies

Outcome Measures

Primary Outcomes (3)

• Incidence of dose limiting toxicities (DLTs)

  The incidence of dose-limiting toxicity (DLT) at different doses of BC2027 in patients with advanced solid malignancies

  Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 28 or 21 days).

• The safety and tolerability

  To assess the safety and tolerability of BC2027 in patients with advanced solid malignancies

  Through study completion, an average of 2 years.

• Preliminary antitumor activity

  To assess the preliminary antitumor activity of BC2027 in patients with advanced solid malignancies

  Through study completion, an average of 2 years.

Study Arms (1)

BC2027 treatment group

EXPERIMENTAL

BC2027 is administered via IV infusion, with 2 phases: * Phase Ia (dose escalation): 4 levels (0.8/1.2/1.8/2.4 mg/kg); first 3 levels: Q2W (28-day cycle); 4th level: simultaneous exploration of Q2W (28-day cycle) and Q3W (21-day cycle). * Phase Ib (dose expansion): 3 GPC3-positive cohorts (NSCLC/HCC/others) treated at Phase Ia's recommended dose.

Drug: BC2027 for Injection

Interventions

BC2027 for Injection DRUG

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.

BC2027 treatment group

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent.
• Be at least 18 years old.
• Have an Eastern Cooperative Group (ECOG) performance status (PS) of 0 or 1.
• Have a life-expectancy of at least 3 months based on the Investigator's assessment.
• Patients with advanced solid tumors confirmed by histology or cytology, who have failed standard therapy, have no available standard therapy, or are intolerant to standard therapy.
• Phase 1a (dose escalation, Part 1)
• a. Have an advanced solid malignancy confirmed by histologic or cytologic examination that is known to express GPC3 including, but not limited to, HCC, NSCLC (particularly squamous cell NSCLC), sarcoma (undifferentiated), ovarian clear cell adenocarcinoma (OCCC), esophageal squamous cell carcinoma (ESCC).
• Must provide either a previously archived tumor tissue sample or a fresh core or excisional biopsy from a site that was not irradiated. There must be at least 3-5 unstained sections. A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred to slides, and fresh biopsies are preferred over archival tissue. If archival tissue cannot be provided and a fresh biopsy cannot be obtained in Part 1, an exemption may be provided by the Sponsor.
• Must have adequate organ function within 7 days prior to the start of study treatment as defined below:
• Hematological\* ANC ≥1,500/μL or ≥1.5×109/L Platelets ≥100,000/μL or ≥100×109/L (For HCC patients, PLTs ≥75×109/L) Hemoglobin ≥9.0 g/dL Kidney Function Creatinine clearance (CrCl)\*\* ≥50 mL/min Liver Function Total Bilirubin (TBIL) ≤1.5×ULN, or direct bilirubin ≤ULN (patients with total bilirubin level \>1.5×ULN).
• AST (SGOT) and ALT (SGPT) ≤2.5×ULN (≤5×ULN in patients with liver metastases) Coagulation International Normalized Ratio (INR), Prothrombin Time (PT), and activated partial thromboplastin time (aPTT) :INR≤1.5; PT and aPTT ≤1.5×ULN or within a therapeutic range if on an anticoagulant.
• \* Blood transfusion or growth factor support is not allowed within 14 days prior to blood sampling.
• \*\* CrCl should be calculated according to institutional standards.
• Must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (In the dose escalation part of the study (Part 1), patients without measurable lesions may be enrolled if they have evaluable disease and are approved by the sponsor). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Must agree to use highly effective contraceptive measures if patient is a man or woman of childbearing potential. Highly effective contraceptive measures include measures like hormonal contraceptives, intrauterine devices, vasectomy, or tubal ligation, and others (Section 5.3), from the time of signing the informed consent until 6 months after the last dose of the study drug. Women of childbearing potential (WCBP) must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug. Female patients with surgically sterile or are postmenopausal for at least 12 months without an alternative medical cause are also allowed.

You may not qualify if:

• Prior treatment with GPC3-targeted ADC.
• Prior treatment with systemic anticancer treatment, including investigational agents, within a period that is less than five half-lives or 2 weeks before the start of treatment, whichever is shorter.
• Known hypersensitivity or delayed hypersensitivity reactions to the same class and/or any component of BC2027.
• Treatment with strong CYP3A4 inhibitors or inducers, and P-gp inhibitors within 14 days or 5 half-lives whichever is shorter, before the first dose.
• For patients with advanced NSCLC:
• a. Positive for driver oncogenes: including EGFR mutation, ALK gene fusion, ROS1 gene fusion, KRAS-G12C mutation, c-MET (exon 14 skipping, MET amplification and overexpression), HER2 mutation, RET gene fusion, etc.
• For HCC patients:
• Received local hepatic therapy including, but not limited to, surgery, radiotherapy, hepatic arterial embolization (TAE), hepatic arterial chemoembolization (TACE), hepatic arterial perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to initiation of the study drug.
• History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy)
• The patient has main portal vein thrombosis ((i.e. thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.)
• Documented gastrointestinal bleeding within past 6 months or at high risk of gastrointestinal bleeding per investigator's clinical judgement, due to esophageal varices, active gastric or duodenal ulcers.
• Active and severe viral infections meeting the following criteria:
• Known HIV seropositivity.
• Known active hepatitis B (Screening for hepatitis B is not required for non-HCC patients):
• For HCC patients: HBV DNA \> 2000 IU/mL. (For patients with positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/mL)\], patients with the following conditions may be enrolled: patients who have received antiviral therapy and had sufficient suppression of viral replication before enrollment (HBV DNA ≤ 2000 IU/ml), and patients must continue to receive antiviral therapy during the study and for 6 months after the last dose.)

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai, China, 200030, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Feng Liu

CONTACT

+86 021 6296 6868; feng.liu@biocitypharma.com

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: January 12, 2026
• First Posted: January 26, 2026
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CN (1)