NCT05892718招募中1 期
A Phase 1, Open-label, Multi-center, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HCB101 in Subjects With Advanced Solid Tumors or Relapsed and Refractory Non-Hodgkin Lymphoma
FBD Biologics Limited15 个研究点 分布在 3 个国家目标入组 80 人开始时间: 2023年10月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 15
- 主要终点
- Number/incidence and percentage of subjects with adverse events, including ADA.
研究概览
简要总结
The purpose of this study is to find out whether IV injection of HCB101 is an effective treatment for different types of advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.
详细描述
This is an open-label, multi-center, dose-escalation, Phase 1 study. This study is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and identification of maximum tolerated dose (MTD) of HCB101 intravenous injection in adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.
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 consent, loss to follow-up, death, or termination of the study, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and willing to sign the ICF.
- •Male and female subjects of ≥18 years of age.
- •Histologically/cytologically confirmed, locally advanced solid tumor: subjects with histologically or cytologically confirmed advanced solid tumors refractory to standard therapy, or for which no standard treatment exists or non-Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of therapy.
- •For subjects with advanced solid tumor - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
- •For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement).
- •Must have ECOG performance status of 0 to 2 at Screening.
- •Able to provide tumor tissue samples.
- •Have life expectancy of ≥12 weeks.
排除标准
- •With known history of hypersensitivity to any components of HCB
- •Known active or untreated CNS metastases and/or carcinomatous meningitis.
- •Have undergone a major surgery or radical radiotherapy or palliative radiotherapy or have used a radioactive drug that is not completed at least 2 weeks prior to the first dose of HCB
- •Clinically significant cardiovascular condition.
- •Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia.
- •With known inherited or acquired bleeding disorder or bleeding diathesis. .
- •Have RBC transfusion within 4 weeks prior to Screening.
- •With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
- •Any investigational or approved systemic cancer therapy.
- •Active use of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on case by case basis. There will be no restriction for daily aspirin ≤ 81 mg/QD.
- •Have used herbal medication within 14 days prior to the first dose of HCB
- •Have received any treatment targeting the CD47 or SIRPα pathway.
- •Have other malignancies requiring treatment within 2 years prior to the first dose of HCB
- •Participation in another clinical study with an investigational product administered in the last 14 days prior to receiving the first dose of HCB
- •An investigational device used within 28 days prior to the first dose of HCB
- •Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
- •Known to have a history of alcoholism or drug abuse.
研究组 & 干预措施
HCB101
Experimental
HCB101 in subjects with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.
Dosage levels: 0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.64 mg/kg, 1.28 mg/kg, 2.56 mg/kg, 5.12 mg/kg, 8.00 mg/kg, 12.00 mg/kg, 18.00 mg/kg, 24.00 mg/kg, 30.00 mg/kg and 36 mg/kg sequentially.
干预措施: HCB101 (Drug)
结局指标
主要结局
Number/incidence and percentage of subjects with adverse events, including ADA.
时间窗: 12 months
To evaluate the safety and tolerability of HCB101
Number of subjects with MTD of HCB101
时间窗: 12 months
To evaluate the safety and tolerability of HCB101
次要结局
- Progression-Free Survival (PFS)(12 months)
- Peak Plasma Concentration (Cmax) of HCB101(12 months)
- Disease Control Rate (DCR)(12 months)
- Area under the plasma concentration versus time curve (AUC) of HCB101(12 months)
- Overall Rate Response (ORR)(12 months)
- Duration of Response (DoR)(12 months)
- Time to maximum drug concentration in plasma (Tmax) of HCB101(12 months)
- Terminal elimination half-life (t1/2) of HCB101(12 months)
研究者
研究点 (15)
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相关资讯
FDA Clears HanchorBio's HCB101 Single-Patient Expanded Access Protocol, a First for SIRPα-Fc Fusion Proteins- The FDA has cleared HanchorBio's HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," allowing continued dosing beyond the parent Phase 1 study.
- The protocol extends HCB101 treatment for one patient who experienced clinical benefit in the Phase 1 trial and has limited remaining treatment options.
- HanchorBio believes HCB101-EA-001 is the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein, distinct from prior anti-CD47 antibody programs.
- HCB101 is an investigational SIRPα-IgG4 Fc fusion protein blocking CD47-SIRPα signaling, studied as monotherapy and in combination with Orphan Drug Designation in gastric cancer.8 days agoHanchorBio's HCB101 Shows Promising Safety Profile and Early Efficacy in Phase 1 Cancer Trial- HanchorBio presented Phase 1 results for HCB101, a novel SIRP⍺-engineered Fc fusion protein, showing favorable safety with only one dose-limiting toxicity among 49 patients across 10 dose levels.
- The therapy achieved >90% CD47 receptor occupancy at doses ≥1.28 mg/kg and demonstrated confirmed partial responses in head and neck squamous cell carcinoma and non-Hodgkin lymphoma patients.
- HCB101's engineered design effectively mitigated anemia and cytopenias commonly associated with earlier anti-CD47 therapies, while maintaining strong immune activation capabilities.
- The company also announced upcoming presentations of HCB301, a tri-specific checkpoint immunotherapy targeting CD47-SIRP⍺, PD-1, and TGF-β pathways, across five major oncology meetings in Q4 2025.11 months agoHanchorBio Secures $202M Licensing Deal with Henlius for Novel CD47-Targeting Cancer Immunotherapy- HanchorBio signed a major licensing agreement with Shanghai Henlius Biotech worth up to $202 million for exclusive rights to HCB101 across Greater China, Southeast Asia, and MENA regions.
- HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein that selectively blocks CD47 signals while reducing hematologic toxicity compared to earlier CD47-targeted agents.
- Phase 1 clinical data showed two confirmed partial responses in head and neck cancer and marginal zone lymphoma patients, with the drug now advancing to multi-regional Phase 2 trials.
- The deal includes $10 million upfront payment and up to $192 million in milestone payments, positioning HCB101 as a key asset in the competitive immuno-oncology market.last yearHanchorBio's HCB101 Checkpoint Inhibitor Shows Promising Safety and Efficacy Balance in Phase 1b Trial- HanchorBio presented interim Phase 1b data for HCB101, a CD47-targeting checkpoint inhibitor, at the 2025 ASCO Annual Meeting showing favorable safety and tolerability across escalating doses.
- The treatment demonstrated early anti-tumor activity with confirmed partial responses in head and neck cancer and non-Hodgkin's lymphoma patients, while achieving high-level CD47 receptor occupancy.
- HCB101 achieved a 26.7% disease control rate in Phase 1a data with 100% safety across all dose levels, addressing the traditional trade-off between safety and efficacy in checkpoint inhibitor treatments.
- The company has launched a multi-region Phase 2 trial spanning Taiwan, the United States, and China, enrolling patients with multiple cancer types including lung, head and neck, stomach, and breast cancers.last year