New combo therapy hopes to shrink Hard-to-Treat cancers
NCT ID NCT06771622
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called HCB101 given together with other cancer treatments for people with advanced solid tumors that have not responded well to prior therapy. About 500 adults will take part to find the safest dose and see if the combination can shrink tumors. The goal is to control the disease, not to cure it, as ongoing treatment is expected.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects are able to understand and willing to provide signed informed consent. 2. Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent. 3. With histologically/cytologically confirmed diagnosis of advanced solid tumors as described below: 1\) Cohort 1- Gastric Cancer, HER-Positive (First-Line): 2) Cohort 2 - Gastric Cancer (Second-Line): 3) Cohort 3 - Colorectal Cancer (Second-Line): 4) Cohort 4 - Triple-Negative Breast Cancer (First-Line): 5) Cohort 5 - Gastric Cancer, HER2 Medium/Low/Negative (First-Line): 6) Cohort 6 - Head and Neck Squamous Cell Carcinoma: 7) Cohort 7 - Ovarian Cancer: 8) Cohort 8 - Hepatocellular Carcinoma: 9) Cohort 9 - Extensive-Stage Small Cell Lung Cancer: 4. Have adequate organ function, as indicated by the following laboratory parameters below (had not received a blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 14 days before the administration of the first dose of study intervention). Exclusion Criteria: 1. With a known history of hypersensitivity to any components of the study intervention. 2. Prior/Concomitant Therapy/Treatment: 1. Subjects who have undergone major surgery or radical radiotherapy within 28 days before the first dose of study intervention. 2. Subjects who have received systemic antitumor therapies within the following washout periods prior to the first dose of study intervention: * 28 days for curative radiotherapy, immunotherapy, or targeted therapy, etc. * 14 days for chemotherapy, palliative radiotherapy, endocrine therapy, or herbal medicine or traditional therapies with known or claimed antitumor activity. 3. Subjects who have used a radioactive drug (Strontium, Samarium, etc.) within 56 days before the first dose of the study intervention. 4. Subjects who are active using of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on a case-by-case basis. Daily low dose of aspirin use (≤ 100 mg QD in Mainland China; ≤ 81 mg QD in the United States) is allowed. 5. Subjects who have received any treatment targeting the CD47 or SIRPα pathway. 6. Subjects who have received or plan to receive live virus or bacterial vaccine within 28 days before the first dose of study intervention while the subject receives the study intervention. 3. Participation in another clinical study with an investigational product administered or investigational device used in the last 28 days (If half-life is not clear) or 5 half-lives (If half-life is clear, the longer time one prevails) before receiving the first dose of study intervention. 4. Subjects who have received any treatment targeting the CD47 or SIRPα pathway. 5. An uncontrolled acute infection. 6. Known to have a history of alcoholism or drug abuse. 7. Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
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