Testing HCB101 for advanced solid tumors and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial evaluates the safety and efficacy of HCB101, an intravenous Fc-fusion protein targeting the SIRPα-CD47 pathway, in adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. The study is open-label and multi-center, focusing on determining the maximum tolerated dose (MTD) while assessing pharmacokinetics and anti-tumor activity. Eligible participants must have previously failed standard therapies or be deemed unsuitable for them, and they will be monitored for side effects and disease progression throughout the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able to understand and willing to sign the ICF.
2. Male and female subjects of ≥18 years of age.
3. 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.
4. 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.
5. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement).
6. Must have ECOG performance status of 0 to 2 at Screening.
7. Able to provide tumor tissue samples.
8. Have life expectancy of ≥12 weeks.

Exclusion Criteria:

1. With known history of hypersensitivity to any components of HCB101.
2. Known active or untreated CNS metastases and/or carcinomatous meningitis.
3. 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 HCB101.
4. Clinically significant cardiovascular condition.
5. 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.
6. With known inherited or acquired bleeding disorder or bleeding diathesis. .
7. Have RBC transfusion within 4 weeks prior to Screening.
8. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
9. Any investigational or approved systemic cancer therapy.
10. 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.
11. Have used herbal medication within 14 days prior to the first dose of HCB101.
12. Have received any treatment targeting the CD47 or SIRPα pathway.
13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB101.
14. Participation in another clinical study with an investigational product administered in the last 14 days prior to receiving the first dose of HCB101.
15. An investigational device used within 28 days prior to the first dose of HCB101.
16. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
17. Known to have a history of alcoholism or drug abuse.

Where it's running

• Hematology-Oncology Associates of the Treasure Coast
  Port Saint Lucie, Florida, United States Recruiting
• Carolina BioOncology
  Huntersville, North Carolina, United States Recruiting
• Greenville Hospital System University Medical Center (ITOR)
  Greenville, South Carolina, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Hangzhou First People's Hospital
  Hangzhou, Zhejiang, China Recruiting
• Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
  New Taipei City, Taiwan Recruiting

Study contacts

• Study coordinator: FBD Clinical
• Email: HCB101-101@hanchorbio.com
• Phone: +886-2-27921366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.