A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05229601
• Other study ID #: HFB-301001-01
• Secondary ID: 2021-004854-46
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 20, 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: HiFiBiO Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
United States	University of Maryland	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	NEXT Virginia Cancer Specialists	Fairfax	Virginia
United States	Mayo Clinic	Jacksonville	Florida
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
HiFiBiO Therapeutics

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)
Primary	To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion		Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)
Secondary	Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 and immune-RECIST (iRECIST)		Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years
Secondary	Disease Control Rate (DCR) as determined by RECIST1.1 and iRECIST		Baseline to 30 days after the last dose of HFB301001 (each cycle is 28 days), assessed up to 3 years
Secondary	Duration of Response (DOR) as determined by RECIST1.1 and iRECIST		Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years
Secondary	Progression Free Survival (PFS) as determined by RECIST1.1 and iRECIST		Baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Secondary	Minimum serum concentration (Cmin)		Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Secondary	Maximum serum concentration (Cmax)		Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Secondary	Area under the concentration versus time curve (AUC)		Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Secondary	Terminal half-life (T1/2)		Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Secondary	Serum concentration for measurement of anti-HFB301001 antibodies		Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)
Secondary	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	Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)