Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Experimental cancer drug trial halted early

NCT ID NCT05229601

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

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

Participants

31 people

The number who actually took part.

Started

Apr 2022

Finished

May 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

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: * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Head and neck squamous cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • 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

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.