A Phase 1, Open-label, Multicenter, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HCB301 in Subjects With Advanced Solid Tumors or Relapsed and Refractory cHL
FBD Biologics Limited
Summary
The purpose of this study is to find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.
Description
This is a phase 1, open-label, multicenter, dose-escalation study. This study is to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and identification of maximum tolerated dose (MTD) of HCB301 intravenous injection in adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. Eligible subjects must have failed standard therapies, been intolerable, or been considered medically inappropriate by the investigator. Subjects will be treated until unacceptable AEs, radiographic or clinical documented disease progression, withdrawal of co…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to understand and be willing to sign the ICF. 2. Male and female subjects of ≥18 years of age. 3. Histologically/cytologically confirmed, locally advanced solid tumor: subjects confirmed advanced solid tumors who have relapsed or refractory and should have no options for standard or approved therapies known to potentially confer clinical benefit or classical Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of systemic therapy. 4. For subjects with advanced solid tumors - must have at least 1 measurable lesion as defined by Response Evaluation…
Interventions
- DrugHCB301
HCB301 administered via. intravenous (IV) infusion.
Locations (7)
- Prisma Health-UpstateGreenville, South Carolina
- The First Affiliated Hospital, Zhejiang University School of MedicineHangzhou
- Zhejiang Provincial Cancer HospitalHangzhou
- Xuzhou Central HospitalXuzhou
- Yantai Yuhuangding HospitalYantai
- Southern Medical University Zhujiang HospitalZhujiang