Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies
Led by Biocity Biopharmaceutics Co., Ltd. · Updated on 2026-01-26
180
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Be at least 18 years old.
- Have an Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- Have advanced solid tumors confirmed by histology or cytology, with no effective standard therapy or intolerance to such therapy.
- In Phase 1a, have tumors known to express GPC3 including HCC, NSCLC (especially squamous cell), sarcoma (undifferentiated), ovarian clear cell adenocarcinoma, or esophageal squamous cell carcinoma.
- Provide a tumor tissue sample or fresh biopsy, preferably formalin-fixed and paraffin-embedded.
- Have adequate organ function within 7 days before treatment as defined by blood counts, kidney, liver function, and coagulation measures.
- Have at least one measurable tumor lesion per RECIST 1.1, or evaluable disease approved by sponsor in dose escalation.
- Agree to use effective contraception if of childbearing potential, with negative pregnancy test for women.
- For Phase 1b cohorts, meet specific criteria including confirmed GPC3 expression and prior therapy history depending on the cancer type.
You will not qualify if you...
- Prior treatment with GPC3-targeted antibody drug conjugates.
- Recent systemic anticancer treatment within 2 weeks or five half-lives.
- Known hypersensitivity to BC2027 or its components.
- Recent use of strong CYP3A4 or P-gp inhibitors or inducers.
- For NSCLC patients, presence of certain driver oncogene mutations.
- For HCC patients, recent local liver therapies, history of hepatic encephalopathy, main portal vein thrombosis, recent gastrointestinal bleeding, or high bleeding risk.
- Active severe viral infections including HIV or uncontrolled hepatitis B or C.
- Severe immunodeficiency requiring corticosteroids or other immunosuppressives.
- History of organ transplantation.
- Recent radiotherapy or radiation pneumonitis.
- Unstable brain metastases or carcinomatous meningitis.
- Uncontrolled pleural, pericardial effusions, or ascites.
- History or evidence of interstitial lung disease.
- Significant cardiovascular disease or ECG abnormalities.
- Severe peripheral neuropathy or unresolved toxicities from prior treatments.
- Active eye diseases affecting monitoring.
- Active infections requiring systemic treatment.
- Poor compliance or unwillingness to follow study procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai, China, China, 200030
Actively Recruiting
Research Team
F
Feng Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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