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New treatment option for Advanced Solid Tumor
Official title An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors
ClinicalTrials.gov ID: NCT06487624
What this study is testing
What is HCB301?
HCB301 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 2023-3979 Solid Tumors.
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 HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas 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 be willing to sign the ICF.
- Male and female people of ≥18 years of age.
- Histologically/cytologically confirmed, locally advanced solid tumor: people confirmed advanced solid tumors who have relapsed or refractory and...
- For people with advanced solid tumors - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST)...
- For people with classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
You likely can't join if
- With known history of hypersensitivity to any components of HCB301.
- Known active or untreated CNS metastases and/or carcinomatous meningitis.
- Have undergone a major surgery or radical radiotherapy within 28 days or palliative radiotherapy within 14 days or have used a radioactive drug...
- 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 be willing to sign the ICF.
- Male and female people of ≥18 years of age.
- Histologically/cytologically confirmed, locally advanced solid tumor: people confirmed advanced solid tumors who have relapsed or refractory and should have no options for standard or approved therapies known to...
- For people 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.
- For people with classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
- Must have ECOG performance status of 0 to 1 at Screening.
- Able to provide tumor tissue samples.
- Have a life expectancy of ≥12 weeks.
- With known history of hypersensitivity to any components of HCB301.
- Known active or untreated CNS metastases and/or carcinomatous meningitis.
- 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.
- 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 administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug.
- 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...
- Have used herbal medication within 14 days prior to the first dose of HCB301.
- Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway.
- Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301.
- An investigational device used within 28 days prior to the first dose of HCB301.
- 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
- Greenville, South Carolina, United States
- Hangzhou, China
- Xuzhou, China
- Yantai, China
- Zhujiang, China
- Kaohsiung City, 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 Greenville, South Carolina, United States; Hangzhou, China; Xuzhou, China; Yantai, China; Zhujiang, China; Kaohsiung City, Taiwan. 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.