New drug duo hopes to boost immune system against tough cancers
NCT ID NCT05238883
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new drug called HFB200301, either alone or with another drug (tislelizumab), in 72 adults with advanced solid tumors like lung, stomach, or skin cancer. The main goal is to check safety and find the best dose. Researchers will also watch for any tumor shrinkage, but this is a small, early study, so results are uncertain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HFB200301 (a drug that activates TNFR2) and tislelizumab (an anti-PD-1 antibody)
- What this could lead to
- If successful, this could lead to 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 72 participants, so the drug may not work or could have serious side effects. It is not yet known if it will shrink tumors or improve survival.
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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72 people
The number who actually took part.
- Started
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Mar 2022
- Expected to finish
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Dec 2026
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: * Previously received the following lines of systemic therapy for the advanced/metastatic disease: * Gastric cancer: at least 2 lines of therapy * Renal 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 * Sarcoma: at least 1 line of therapy * Testicular germ cell tumor: at least 2 lines of therapy * Cervical cancer: at least 2 lines of therapy * Mesothelioma: at least 2 lines of therapy * Non-small cell lung cancer: at least 2 lines of therapy * Head and neck squamous cell carcinoma: at least 2 lines 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 or modified RECIST (mRECIST) for mesothelioma * 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 or within 4 weeks for immune-oncologic therapy * For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy * Therapeutic radiation therapy within the past 2 weeks * Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) 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 ≤ 14 days before first dose * Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) 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 4 weeks of the first dose of study drug * History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening * History of allergic reactions, immune related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200301 * Using sensitive substrates of major cytochrome P450 (CYP450) enzymes * Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years * For combination only: * Prior randomization in a tislelizumab study regardless of the treatment arm, until the primary and key secondary endpoints of the study have read out * Hypersensitivity to tislelizumab or any of its excipients.
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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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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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The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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