A Study of HFB301001 in Adult Patients With Advanced Solid Tumors
Primary Purpose
Soft Tissue Sarcoma, Renal Cell Carcinoma, Uterine Carcinosarcoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HFB301001
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma
Eligibility 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
- 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 and 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.
Sites / Locations
- Mayo ClinicRecruiting
- USC/Norris Comprehensive Cancer CenterRecruiting
- Mayo ClinicRecruiting
- University of MarylandRecruiting
- Dana Farber Cancer InstituteRecruiting
- Mayo ClinicRecruiting
- NEXT Virginia Cancer SpecialistsRecruiting
- Hospital Universitario Vall d'HebronRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Clinico Universitario de ValenciaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HFB301001
Arm Description
Participants will receive HFB301001 via intravenous infusions
Outcomes
Primary Outcome Measures
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)
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
Secondary Outcome Measures
Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 and immune-RECIST (iRECIST)
Disease Control Rate (DCR) as determined by RECIST1.1 and iRECIST
Duration of Response (DOR) as determined by RECIST1.1 and iRECIST
Progression Free Survival (PFS) as determined by RECIST1.1 and iRECIST
Minimum serum concentration (Cmin)
Maximum serum concentration (Cmax)
Area under the concentration versus time curve (AUC)
Terminal half-life (T1/2)
Serum concentration for measurement of anti-HFB301001 antibodies
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05229601
Brief Title
A Study of HFB301001 in Adult Patients With Advanced Solid Tumors
Official Title
A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HiFiBiO Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
A Screening Period of up to 28 days
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
A Follow-Up Period which involves 1 visit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma, Renal Cell Carcinoma, Uterine Carcinosarcoma, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma, Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFB301001
Arm Type
Experimental
Arm Description
Participants will receive HFB301001 via intravenous infusions
Intervention Type
Drug
Intervention Name(s)
HFB301001
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Minimum serum concentration (Cmin)
Time Frame
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Title
Maximum serum concentration (Cmax)
Time Frame
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Title
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)
Title
Terminal half-life (T1/2)
Time Frame
Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Title
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)
Title
To assess the pharmacodynamic (PD) effects of HFB301001 in the blood and in the tumor
Description
Percent change in immunologic changes to immune cells in the blood and tumor
Time Frame
Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse Cotugno, Clinical Trial Manager
Phone
+1(513)579-9911
Email
j.cotugno@medpace.com
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
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A Study of HFB301001 in Adult Patients With Advanced Solid Tumors
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