Experimental cancer drug trial halted early
NCT ID NCT05229601
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called HFB301001 in 31 adults with advanced solid tumors (like sarcoma, kidney cancer, or melanoma) that had not responded to prior treatments. The main goal was to check the drug's safety and find the best dose. The study was terminated, so results are limited.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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31 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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May 2024
- 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: * Previously received the following lines of systemic therapy for the advanced/metastatic disease: * Soft tissue sarcoma: at least 1 line of therapy * Renal cell carcinoma: at least 2 lines of therapy; * Uterine carcinosarcoma: at least 1 line of therapy; * Hepatocellular carcinoma: at least 1 line of therapy * Head and neck squamous cell carcinoma: at least 2 lines of therapy * Melanoma: * BRAF V600E mutant: must have received at least 2 lines of therapy * BRAF V600E wild type: must have received at least 1 line of therapy * Suitable site to biopsy at pre-treatment and on-treatment * Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST) * Eastern Cooperative Oncology Group performance status of 0 or 1. Exclusion Criteria: * Systemic anti-cancer therapy within 2 weeks prior to start of study drug. * For soft tissue sarcoma only: prior immune therapy or immune agonist antibodies * For uterine carcinosarcoma patients only: prior immune therapy * Therapeutic radiation therapy within the past 2 weeks * Prior exposure to agents targeting the OX40 receptor; * Active autoimmune disease requiring systemic treatment in the previous 2 years; * Systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any immune suppressive therapy. * Persisting toxicity of \>Grade 1 relating to prior anti cancer therapy with the following exceptions: * All grades of alopecia are acceptable; * Endocrine dysfunction on replacement therapy is acceptable. * Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition; * Major surgery within 2 weeks of the first dose of study drug; * History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2; * History of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB301001; * Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years.
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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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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
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Mayo Clinic
Scottsdale, Arizona, 85259, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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NEXT Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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University of Maryland
Baltimore, Maryland, 21201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can turbocharged immune cells stop liver cancer from coming back?