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A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05229601
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
HiFiBiO Therapeutics

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Renal Cell Carcinoma Uterine Carcinosarcoma Hepatocellular Carcinoma Head and Neck Squamous Cell Carcinoma Melanoma Drug: HFB301001 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors
Actual Study Start Date : April 20, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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) [ Time Frame: 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 [ Time Frame: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Minimum serum concentration (Cmin) [ Time Frame: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days) ]
  6. Maximum serum concentration (Cmax) [ Time Frame: 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) [ Time Frame: Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days) ]
  8. Terminal half-life (T1/2) [ Time Frame: 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 [ Time Frame: 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 [ 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05229601


Contacts
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Contact: Jesse Cotugno, Clinical Trial Manager +1(513)579-9911 j.cotugno@medpace.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Virginia
NEXT Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
HiFiBiO Therapeutics
More Information
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Responsible Party: HiFiBiO Therapeutics
ClinicalTrials.gov Identifier: NCT05229601    
Other Study ID Numbers: HFB-301001-01
2021-004854-46 ( EudraCT Number )
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Sarcoma
Squamous Cell Carcinoma of Head and Neck
Carcinosarcoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Head and Neck Neoplasms
Neoplasms, Complex and Mixed