Treatment for advanced tumors using HCB301

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

This study is testing a new treatment called HCB301 to see if it can safely help adults with advanced tumors or relapsed Hodgkin lymphoma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: FBD Biologics Limited (Industry-sponsored)
• Locations: 7 sites (Greenville, South Carolina and 6 other locations)
• Trial ID: NCT06487624 on ClinicalTrials.gov

What this trial studies

This phase 1, open-label, multicenter trial evaluates the safety and effectiveness of HCB301, an engineered fusion protein, administered intravenously to adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphoma. The study aims to determine the maximum tolerated dose and assess pharmacokinetics and preliminary efficacy. Participants will receive treatment until they experience unacceptable side effects, disease progression, or other specified criteria are met.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors or relapsed classical Hodgkin lymphoma who have exhausted standard treatment options.

Not a fit: Patients with tumors that are not advanced or those who have not failed previous therapies may 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 Hodgkin lymphoma.

How similar studies have performed: Other studies using immunotherapy approaches have shown promise, but this specific combination is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and be willing to sign the ICF.
2. Male and female subjects of ≥18 years of age.
3. Histologically/cytologically confirmed, locally advanced solid tumor:

   subjects confirmed advanced solid tumors who have relapsed or refractory and should have no options for standard or approved therapies known to potentially confer clinical benefit or classical Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of systemic therapy.
4. For subjects with advanced solid tumors - 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 classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
6. Must have ECOG performance status of 0 to 1 at Screening.
7. Able to provide tumor tissue samples.
8. Have a life expectancy of ≥12 weeks.

Exclusion Criteria:

1. With known history of hypersensitivity to any components of HCB301.
2. Known active or untreated CNS metastases and/or carcinomatous meningitis.
3. Have undergone a major surgery or radical radiotherapy within 28 days or palliative radiotherapy within 14 days or have used a radioactive drug within 56 days prior to the first dose of HCB301.
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 administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug.
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 ≤ 100 mg/QD.
11. Have used herbal medication within 14 days prior to the first dose of HCB301.
12. Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway.
13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301.
14. An investigational device used within 28 days prior to the first dose of HCB301.
15. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
16. Known to have a history of alcoholism or drug abuse.

Where this trial is running

Greenville, South Carolina and 6 other locations

• Prisma Health-Upstate — Greenville, South Carolina, United States (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
• Zhejiang Provincial Cancer Hospital — Hangzhou, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, China (Recruiting)
• Yantai Yuhuangding Hospital — Yantai, China (Recruiting)
• Southern Medical University Zhujiang Hospital — Zhujiang, China (Recruiting)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)

Study contacts

• Study coordinator: FBD Clinical

Conditions Advanced Solid Tumor; Refractory Hodgkin Lymphoma; Immunotherapy; CD47; PD-L1; TGF-beta; Tumor; Cancer