RecruitingPhase 1NCT06487624

An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors

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


Sponsor

FBD Biologics Limited

Enrollment

50 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a new cancer drug called HCB301 — an engineered protein that combines multiple immune-blocking mechanisms — in adults with advanced solid tumors or classical Hodgkin lymphoma that has stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor that has relapsed or is resistant to all available standard treatments - You have classical Hodgkin lymphoma that has failed at least 2 prior treatment regimens - You have at least one measurable or assessable tumor - You have a good performance status (ECOG 0-1) - You are willing to provide a tumor tissue sample - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have a known allergy to any component of HCB301 - You have active, untreated cancer spread to the brain - You had major surgery or extensive radiation within the past 28 days - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHCB301

HCB301 administered via. intravenous (IV) infusion.


Locations(7)

Prisma Health-Upstate

Greenville, South Carolina, United States

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Provincial Cancer Hospital

Hangzhou, China

Xuzhou Central Hospital

Xuzhou, China

Yantai Yuhuangding Hospital

Yantai, China

Southern Medical University Zhujiang Hospital

Zhujiang, China

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06487624


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