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New drug duo hopes to boost immune system against tough cancers

NCT ID NCT05238883

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

72 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • NEXT Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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