Status:
TERMINATED
A Study of HFB301001 in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
HiFiBiO Therapeutics
Conditions:
Soft Tissue Sarcoma
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 w...
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 Tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05229601
Start Date
April 20 2022
End Date
May 30 2024
Last Update
October 22 2025
Active Locations (10)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
University of Maryland
Baltimore, Maryland, United States, 21201