A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

NCT ID: NCT05229601

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2024-05-30

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

Conditions

Soft Tissue Sarcoma; Renal Cell Carcinoma; Uterine Carcinosarcoma; Hepatocellular Carcinoma; Head and Neck Squamous Cell Carcinoma; Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HFB301001

Participants will receive HFB301001 via intravenous infusions

Group Type: EXPERIMENTAL

HFB301001

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HiFiBiO Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic

Scottsdale, Arizona, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Mayo Clinic

Jacksonville, Florida, United States

University of Maryland

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

NEXT Virginia Cancer Specialists

Fairfax, Virginia, United States

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Countries

United States; Spain

Other Identifiers

2021-004854-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HFB-301001-01

Identifier Type: -

Identifier Source: org_study_id