Testing HCB101 for advanced solid tumors and lymphoma

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

This study is testing a new treatment called HCB101 to see if it can help adults with advanced solid tumors or certain types of lymphoma that haven't responded to other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: FBD Biologics Limited (Industry-sponsored)
• Locations: 8 sites (Port Saint Lucie, Florida and 7 other locations)
• Trial ID: NCT05892718 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma who have failed prior treatments.

Not a fit: Patients with known hypersensitivity to any components of HCB101 will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors and refractory non-Hodgkin lymphoma.

How similar studies have performed: While this approach is novel, similar immunotherapy strategies targeting the CD47 pathway have shown promise in other studies.

Eligibility criteria

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 this trial is running

Port Saint Lucie, Florida and 7 other locations

• 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)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: FBD Clinical

Conditions Advanced Solid Tumor; Refractory Non-Hodgkin Lymphoma; Immunotherapy; CD47; SIRPα; Solid Tumor; Lymphoma