A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

October 20, 2025 updated by: HiFiBiO Therapeutics

A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors

The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a Phase I, first-in-human, open-label, dose escalation and expansion study in adult patients with advanced cancers. The study will comprise of:

  1. A Screening Period of up to 28 days
  2. A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 28 days. Number of cycles depends on how the disease responds to the study drug
  3. A Follow-Up Period which involves 1 visit

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFB301001
Participants will receive HFB301001 via intravenous infusions
Drug: HFB301001

Dose Escalation: Participants will be administered dose level 1 in Cohort 1. Participants in Cohorts 2-4 will receive dose levels 2-4, respectively.

Dose Expansion: Participants with certain cancer types will be administered the dose determined at dose escalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
Time Frame: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)
Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)
Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs and ECG parameters, and tolerability (dose interruptions, reductions, and dose intensity)
Time Frame: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)
Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 and immune-RECIST (iRECIST)
Time Frame: Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years
Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years
Disease Control Rate (DCR) as determined by RECIST1.1 and iRECIST
Time Frame: Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years
Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years
Duration of Response (DOR) as determined by RECIST1.1 and iRECIST
Time Frame: Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years
Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years
Progression Free Survival (PFS) as determined by RECIST1.1 and iRECIST
Time Frame: Baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Minimum serum concentration (Cmin)
Time Frame: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Maximum serum concentration (Cmax)
Time Frame: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Area under the concentration versus time curve (AUC)
Time Frame: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Terminal half-life (T1/2)
Time Frame: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Serum concentration for measurement of anti-HFB301001 antibodies
Time Frame: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
To assess the pharmacodynamic (PD) effects of HFB301001 in the blood and in the tumor
Time Frame: Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)
Percent change in immunologic changes to immune cells in the blood and tumor
Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HiFiBiO Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFB-301001-01
  • 2021-004854-46 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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