Experimental antibody HH-101 tested in 12 patients with advanced cancers
NCT ID NCT07554196
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested an experimental drug called HH-101 in 12 people with advanced solid tumors that had not responded to standard treatments. The main goal was to check the drug's safety and find the right dose. Participants received HH-101 as an IV infusion every three weeks. The study is now complete, but results on effectiveness are not yet available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HH-101 (an experimental antibody drug given by IV infusion)
- What this could lead to
- If safe and effective, HH-101 could become a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 12 participants, so it is too small to prove effectiveness. The drug may cause side effects or fail to shrink tumors in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Mar 2024
- Lead sponsor
-
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 to 75 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary signing of the written informed consent form; * Histologic or cytologic confirmation of advanced solid tumor; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * Have an estimated life expectancy ≥3 Months, in the judgement of the investigator; * Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Exclusion Criteria: * History of other malignancies within 5 years prior to the first dose of study drug, except for malignancies that have been cured after treatment, such as thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the breast. * Receipt of the last systemic anti-tumor therapy within 2 weeks prior to the first dose of study drug, including chemotherapy, radiotherapy, targeted therapy, or traditional Chinese herbal medicine or patent Chinese medicines with anti-tumor activity. Patients who received tumor immune checkpoint inhibitor therapy within 4 weeks prior to the first dose of study drug. * Adverse reactions from previous treatments that have not recovered to CTCAE v5.0 Grade 1 or lower (except for alopecia and neuropathy, which, in the Investigator's judgment, are long-standing and not expected to recover). * Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * If female, is pregnant, breastfeeding, or planning to become pregnant. * Known hypersensitivity to HH-101 Injection or any of its components. History of severe hypersensitivity reactions to other therapeutic antibody drugs. Known allergy to multiple substances or history of severe allergic diseases. * Known interstitial lung disease or non-infectious pneumonitis requiring steroid therapy. * Other severe, acute, or chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the Investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study 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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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Experimental injection SHR-7787 put to the test against advanced solid tumors
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