Melanoma Clinical Trial

A Study of HFB200301 in Adult Patients With Advanced Solid Tumors

Summary

The purpose of this study is to test the safety and tolerability of HFB200301 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 dose of HFB200301 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 the participants have.

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Full Description

This is a Phase 1, first in human, open-label, dose escalation and expansion study in adults 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.

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Eligibility Criteria

Inclusion Criteria:

Previously received the following lines of systemic therapy for the advanced/metastatic disease:

Gastric cancer: at least 2 lines of therapy
Renal 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
Sarcoma: at least 1 line of therapy
Testicular germ cell tumor: at least 2 lines of therapy
Cervical cancer: at least 2 lines of therapy
Mesothelioma: at least 2 lines of therapy
Non-small cell lung cancer: at least 3 lines 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 or modified RECIST (mRECIST) for mesothelioma
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 testicular germ cell tumor patients only: prior immune therapy
Therapeutic radiation therapy within the past 2 weeks
Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) 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 2 (≥Grade 1 for diarrhea) 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, immune related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200301
Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT05238883

Recruitment Status:

Recruiting

Sponsor:

HiFiBiO Therapeutics

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There are 10 Locations for this study

See Locations Near You

Mayo Clinic
Scottsdale Arizona, 85259, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
The University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
NEXT Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT05238883

Recruitment Status:

Recruiting

Sponsor:


HiFiBiO Therapeutics

How clear is this clinincal trial information?

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