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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Able to understand and be willing to sign the ICF.
• 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.
• For subjects with advanced solid tumors - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
• For subjects with classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
• Must have ECOG performance status of 0 to 1 at Screening.
• Able to provide tumor tissue samples.
• Have a life expectancy of ≥12 weeks.
Locations
United States
South Carolina
Prisma Health-Upstate
RECRUITING
Greenville
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Provincial Cancer Hospital
RECRUITING
Hangzhou
Xuzhou Central Hospital
RECRUITING
Xuzhou
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Southern Medical University Zhujiang Hospital
RECRUITING
Zhujiang
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Contact Information
Primary
FBD Clinical
HCB301-101@hanchorbio.com
+886-2-27921366
Time Frame
Start Date:2025-04-02
Estimated Completion Date:2027-05-31
Participants
Target number of participants:50
Treatments
Experimental: Experimental: 0.3 mg/kg HCB301
0.3 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
Experimental: Experimental: 0.6 mg/kg HCB301
0.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
Experimental: Experimental: 1.2 mg/kg HCB301
1.2 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
Experimental: Experimental: 2.4 mg/kg HCB301
2.4 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
Experimental: Experimental: 4.8 mg/kg HCB301
4.8 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
Experimental: Experimental: 9.6 mg/kg HCB301
9.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
Experimental: Experimental: 15.0 mg/kg HCB301
15.0 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.