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A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05229601
Recruitment Status : Active, not recruiting
First Posted : February 8, 2022
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
HiFiBiO Therapeutics

Tracking Information
First Submitted Date  ICMJE January 19, 2022
First Posted Date  ICMJE February 8, 2022
Last Update Posted Date May 9, 2024
Actual Study Start Date  ICMJE April 20, 2022
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2023)
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2022)
  • Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs and ECG parameters [ Time Frame: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days) ]
  • 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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2022)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Minimum serum concentration (Cmin) [ Time Frame: 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) ]
  • 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) ]
  • Terminal half-life (T1/2) [ Time Frame: 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) ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of HFB301001 in Adult Patients With Advanced Solid Tumors
Official Title  ICMJE A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Soft Tissue Sarcoma
  • Renal Cell Carcinoma
  • Uterine Carcinosarcoma
  • Hepatocellular Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: HFB301001
Participants will receive HFB301001 via intravenous infusions
Intervention: Drug: HFB301001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2022)		 84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05229601
Other Study ID Numbers  ICMJE HFB-301001-01
2021-004854-46 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party HiFiBiO Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE HiFiBiO Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account HiFiBiO Therapeutics
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP