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Tests treatment safety and results for Advanced Solid Malignancies
Official title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT07368478
What this study is testing
What is BC2027 for Injection?
BC2027 for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Patients who meet any of the exclusion criteria must not be enrolled in the study.
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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)...
- 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...
- 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...
- Cohort 1 (NSCLC Cohort)
- Positive expression of GPC3 confirmed by immunohistochemistry (IHC) assay, or with existing prior IHC test report documenting GPC3 positivity.
- Patients with non-small cell lung cancer (NSCLC) who have failed no more than 3 prior lines of systemic antineoplastic therapy.
- Cohort 2 (HCC Cohort)
- IHC evidence of GPC3 expression on archival tumor or a fresh biopsy unless biopsy is not feasible or safe and with approval of the Sponsor.
- The subject has received treatment with 1 prior regimen in the first line advanced setting consisting of an appropriate monoclonal antibody (mAb) targeting PD-1 or PD-L1 with an appropriate mAb targeting CTLA-4 and/or...
- The patient must have Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC (See Appendix 1), not amenable to locoregional therapy or refractory to locoregional therapy likely to result in reasonable clinical benefit...
- The subject has a Child-Pugh A score (See Appendix 2) within 7 days of study drug treatment.
- Cohort 3 (Advanced GPC3 expressing solid cancer).
- GPC3 positivity confirmed by IHC assay, or documented in prior IHC reports.
- Patients excluding Cohort 1 and Cohort 2 with failure of ≤ 2 prior lines of systemic antineoplastic therapy.
What rules you out
- Patients who meet any of the exclusion criteria must not be enrolled in the study.
- 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...
- Received local hepatic therapy including, but not limited to, surgery, radiotherapy, hepatic arterial embolization (TAE), hepatic arterial chemoembolization (TACE), hepatic arterial perfusion, radiofrequency ablation...
- 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...
- For other solid malignancies patients: HBsAg positive and HBV-DNA titer \> 500 IU/mL or \> 2500 copies/mL.
- Known active hepatitis C :
- For HCC patients: Co-infection of HBV and HCV. (The following conditions are allowed for inclusion: positive HCV RNA test or positive HCV antibody, and patients complying with local medical practice for treatment.)
- Severe immunodeficiency requiring systemic corticosteroid therapy at a prednisone-equivalent dose (\>10 mg/day), or any other systemic immunosuppressive therapy, unless approved by the sponsor.
- A history of allogeneic tissue or solid organ transplantation.
- A history of radiation pneumonitis, or receipt of radiotherapy within 2 weeks prior to the initiation of study treatment. Note: Patients must have recovered from radiation-related toxicities and must not be receiving...
- Unstable central nervous system (CNS) metastases and/or carcinomatous meningitis. For patients with previously treated brain metastases who have achieved radiological stability (i.e., no evidence of disease progression...
- Uncontrolled pleural effusion, ascites, or pericardial effusion at the time of screening.
- A history of interstitial lung disease (ILD) or drug-related interstitial lung disease, or any evidence of clinically active interstitial lung disease.
- Clinically significant cardiovascular disease, including but not limited to:
- Congestive heart failure (CHF) of New York Heart Association (NYHA) functional class III or higher, or left ventricular ejection fraction (LVEF) \< 50%.
- Unstable angina pectoris or myocardial infarction occurring within 6 months prior to enrollment.
- Severe cardiac arrhythmias, including but not limited to complete left bundle branch block, atrioventricular block of second degree or higher, and ventricular tachycardia (including frequent ventricular premature beats).
- Clinically uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite anti-hypertensive medication use.
- Clinically significant electrocardiogram (ECG) abnormalities, including any of the following:
- Markedly prolonged QT/QTc interval on screening ECG (i.e., repeated measurements demonstrating a QTc interval \> 470 ms) (QTcF calculated based on the Fridericia formula).
- A history of risk factors for torsades de pointes, such as congestive heart failure, hypokalemia, family history of long QT syndrome, and other risk factors.
- Grade ≥ 2 peripheral neurotoxicity or neuropathy, and other toxicities caused by prior anti-tumor therapy that have not resolved to Grade ≤ 1 (per CTCAE Version 5.0). Exceptions include alopecia, skin hyperpigmentation...
- Patients with active or chronic corneal disease, other active ophthalmic diseases requiring continuous treatment, or any clinically significant corneal disease that prevents adequate monitoring for drug-induced...
- Active infections requiring systemic anti-infective therapy.
- Poor patient compliance, or unwillingness or inability to follow the procedures specified in the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai, China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.