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Soft Tissue SarcomaPhase 1NCT05229601

A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

A Phase 1 study testing HFB301001 in people with Soft Tissue Sarcoma and Renal Cell Carcinoma, run by HiFiBiO Therapeutics at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HFB301001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
10 sitesin 2 countries
Study dates
20 Apr 2022to 30 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States7 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • NEXT Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

Spain3 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: 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.

Read the 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
Being tested
HFB301001
Medical subject headings
Sarcoma, Carcinoma, Renal Cell, Carcinoma, Hepatocellular, Squamous Cell Carcinoma of Head and Neck, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFB301001Drug

    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.

Study groups in NCT05229601
Study groupRoleWhat they receive
HFB301001ExperimentalParticipants will receive HFB301001 via intravenous infusions
Receives: Drug: HFB301001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)

  2. To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

    Measured: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)

Secondary outcomes (10)

  1. Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 and immune-RECIST (iRECIST)

    Measured: Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years

  2. Disease Control Rate (DCR) as determined by RECIST1.1 and iRECIST

    Measured: Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years

  3. Duration of Response (DOR) as determined by RECIST1.1 and iRECIST

    Measured: Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years

  4. Progression Free Survival (PFS) as determined by RECIST1.1 and iRECIST

    Measured: Baseline to disease progression or death, whichever occurs first, assessed up to 3 years

  5. Minimum serum concentration (Cmin)

    Measured: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)

  6. Maximum serum concentration (Cmax)

    Measured: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)

  7. Area under the concentration versus time curve (AUC)

    Measured: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)

  8. Terminal half-life (T1/2)

    Measured: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)

  9. Serum concentration for measurement of anti-HFB301001 antibodies

    Measured: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)

  10. To assess the pharmacodynamic (PD) effects of HFB301001 in the blood and in the tumor

    Percent change in immunologic changes to immune cells in the blood and tumor

    Measured: Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start20 Apr 2022
  3. Primary completion30 May 2024
  4. Study completion30 May 2024

Why it stopped: The decision to discontinue the trial was made as part of a strategic review of the Sponsor's global development portfolio. It is not related to any safety concerns, efficacy findings, recruitment difficulties, or issues with trial conduct.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229601
Sponsor's protocol ID
HFB-301001-01
Other IDs
2021-004854-46
Status last verified
Oct 2025
First submitted
19 Jan 2022
Last updated
22 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zhao J, Zhang D, Lu YY, Jin R, Li F, Zhang Z, Ni W, Gong N, Wang Y, Yin Z, Du Y, Ma W, Wang X, Zu L, Liu S, Yang K, Bai Y, Gan J, Adrian F, Hong Z, Zhang S, Chang Y, Wang Z, Jin X, Zhong J, Ge K, Peng S, Ding D, Zheng W, Xu S, Wang W, Schweizer L, Zhang H. HFB301001, an OX40-based immunotherapy, drives Treg clearance and CTL activation through optimized OX40 receptor clustering. J Immunother Cancer. 2026 Mar 30;14(3):e014185. doi: 10.1136/jitc-2025-014185.

    PubMed 41912269

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HFB301001 in people with Soft Tissue Sarcoma and Renal Cell Carcinoma, run by HiFiBiO Therapeutics at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The decision to discontinue the trial was made as part of a strategic review of the Sponsor's global development portfolio. It is not related to any safety concerns, efficacy findings, recruitment difficulties, or issues with trial conduct.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05229601, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

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