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Tests treatment safety and results for Advanced Solid Tumor
Official title A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
ClinicalTrials.gov ID: NCT05892718
What this study is testing
What is HCB101?
HCB101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Also referred to as SIRPα-Fc fusion protein.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to understand and willing to sign the ICF.
- Male and female people of ≥18 years of age.
- Histologically/cytologically confirmed, locally advanced solid tumor: people with histologically or cytologically confirmed advanced solid tumors...
- For people with advanced solid tumor - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST)...
- For people with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with...
You likely can't join if
- With known history of hypersensitivity to any components of HCB101.
- 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...
- Clinically significant cardiovascular condition.
- Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology...
- With known inherited or acquired bleeding disorder or bleeding diathesis. .
See the full eligibility criteria
- Able to understand and willing to sign the ICF.
- Male and female people of ≥18 years of age.
- Histologically/cytologically confirmed, locally advanced solid tumor: people with histologically or cytologically confirmed advanced solid tumors refractory to standard therapy, or for which no standard treatment exists...
- For people 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 people 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.
- With known history of hypersensitivity to any components of HCB101.
- 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 HCB101.
- 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...
- 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...
- Have used herbal medication within 14 days prior to the first dose of HCB101.
- Have received any treatment targeting the CD47 or SIRPα pathway.
- Have other malignancies requiring treatment within 2 years prior to the first dose of HCB101.
- Participation in another clinical study with an investigational product administered in the last 14 days prior to receiving the first dose of HCB101.
- An investigational device used within 28 days prior to the first dose of HCB101.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Port Saint Lucie, Florida, United States
- Huntersville, North Carolina, United States
- Greenville, South Carolina, United States
- Dallas, Texas, United States
- Hangzhou, Zhejiang, China
- New Taipei City, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Port Saint Lucie, Florida, United States; Huntersville, North Carolina, United States; Greenville, South Carolina, United States; Dallas, Texas, United States; Hangzhou, Zhejiang, China; New Taipei City, Taiwan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.