Actively Recruiting
A Phase 1, Open-label, Multicenter, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HCB301 in Adults With Advanced Solid Tumors or Relapsed and Refractory Classical Hodgkin Lymphoma
Led by FBD Biologics Limited · Updated on 2026-04-13
50
Participants Needed
7
Research Sites
21 weeks
Total Duration
On this page
Sponsors
F
FBD Biologics Limited
Lead Sponsor
H
HanchorBio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating HCB301, an engineered fusion protein given by intravenous injection, as a possible treatment for adults aged 18 and older with various advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. This phase 1, open-label, multicenter study aims to understand the safety, tolerability, how the drug moves through the body, early signs of effectiveness, and the maximum dose that can be given safely. Participants must have tumors that have not responded to standard therapies or are not suitable for them. Participants receive HCB301 at increasing doses ranging from 0.3 mg/kg to 15.0 mg/kg through intravenous infusion. Treatment continues until unacceptable side effects occur, disease progresses as shown by scans or clinical evaluation, the participant chooses to stop, or the study ends. The dosing and escalation allow researchers to identify the best tolerated dose for future studies. During the study, participants will undergo assessments including monitoring for side effects, blood tests to measure drug levels, and evaluation of tumor response using standard criteria. The main outcomes are recording adverse events and determining the maximum tolerated dose over a 12-month period. Secondary outcomes include measuring response rates, how long responses last, disease control, and drug pharmacokinetics. Participants are followed until disease progression, withdrawal, or study completion, which may last up to 12 months.
CONDITIONS
Brief Title
An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent.
- Male and female subjects aged 18 years or older.
- Histologically or cytologically confirmed advanced solid tumors that are relapsed or refractory with no standard therapy options, or classical Hodgkin lymphoma relapsed or refractory after at least two prior systemic therapies.
- For advanced solid tumors, at least one measurable lesion by RECIST v1.1 at baseline.
- For classical Hodgkin lymphoma, measurable or assessable disease for response.
- ECOG performance status of 0 to 1 at screening.
- Able to provide tumor tissue samples.
- Life expectancy of at least 12 weeks.
You will not qualify if you...
- Known allergy to any components of HCB301.
- Active or untreated brain metastases or carcinomatous meningitis.
- Major surgery or radical radiotherapy within 28 days, palliative radiotherapy within 14 days, or radioactive drug use within 56 days prior to first dose.
- Significant cardiovascular conditions.
- Unresolved treatment-related toxicities greater than Grade 1 except alopecia and anemia.
- Known bleeding disorders or recent red blood cell transfusion within 4 weeks.
- Hemolytic anemia or Evans Syndrome diagnosis in last 3 months.
- Recent investigational or approved cancer therapy within 21 days or 5 half-lives before first dose.
- Active use of vitamin K antagonist anticoagulants; low molecular weight heparin and factor Xa inhibitors allowed case-by-case; aspirin up to 100 mg daily allowed.
- Herbal medication use within 14 days prior to first dose.
- Previous treatment targeting SIRPα-CD47, PD-L1, or TGF-β pathways.
- Other malignancies requiring treatment within 2 years before first dose.
- Investigational device use within 28 days prior to first dose.
- Positive for hepatitis B, active hepatitis C, HIV, or active or latent tuberculosis infections.
- History of alcoholism or drug abuse.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until unacceptable adverse events or disease progression
Participants receive intravenous infusions of HCB301 at varying doses. Treatment continues until unacceptable side effects, disease progression, withdrawal, loss to follow-up, death, or study termination.
Repeated visits for intravenous infusions and safety monitoring
Trial Site Locations
Total: 7 locations
1
Prisma Health-Upstate
Greenville, South Carolina, United States, 29605
Actively Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
3
Zhejiang Provincial Cancer Hospital
Hangzhou, China
Actively Recruiting
4
Xuzhou Central Hospital
Xuzhou, China
Actively Recruiting
5
Yantai Yuhuangding Hospital
Yantai, China
Actively Recruiting
6
Southern Medical University Zhujiang Hospital
Zhujiang, China
Actively Recruiting
7
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
Research Team
F
FBD Clinical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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