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

Launched by FBD BIOLOGICS LIMITED · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HCB301, which is given through an IV injection. The aim is to see if this treatment can help people with certain advanced solid tumors and those with Hodgkin lymphoma that has not responded to previous therapies. Researchers want to learn how effective HCB301 is and what side effects it might cause. This study is currently recruiting participants who are 18 years or older and have specific types of cancer that have not improved with standard treatments.

To be eligible for the trial, participants must have a confirmed diagnosis of advanced solid tumors or relapsed Hodgkin lymphoma, and they should have no other treatment options that might help. They also need to have at least one measurable tumor and be in good overall health. If someone decides to participate, they can expect to receive the treatment and be monitored closely for any side effects. It’s important for potential participants to know that they will need to provide tumor tissue samples and meet several health criteria to join the study.

Gender

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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.