A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

NCT05229601 | Terminated Phase 1 FDA Drug

• 2 other identifiers: HFB-301001-012021-004854-46
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 10

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• Minimum serum concentration (Cmin)

  Cycle 1 Day 1 to day of the last dose of HFB301001 (each cycle is 28 days)

Study Arms (1)

HFB301001

EXPERIMENTAL

Participants will receive HFB301001 via intravenous infusions

Drug: HFB301001

Interventions

HFB301001 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.

HFB301001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HiFiBiO Therapeutics: lead

Study Sites (10)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NEXT Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Sarcoma; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Squamous Cell Carcinoma of Head and Neck; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 8, 2022
• Study Start: April 20, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (7); ES (3)