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Clinical Trials in the USA / NCT05238883
Active, not recruiting Phase 1

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

NCT05238883 · tracked via the Priya Life Science USA tracker
Sponsor
HiFiBiO Therapeutics
Phase
Phase 1
Started
2022-03-10
Last updated
2025-11-21

Condition(s) studied

Gastric CancerRenal Cell CarcinomaMelanomaSarcomaTesticular Germ Cell TumorCervical CancerMesotheliomaNon Small Cell Lung CancerHead and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

HFB200301Tislelizumab

HFB200301: Participants will be administered HFB200301 as described in the experimental arm.

Tislelizumab: Participants will be administered tislelizumab as described in the experimental arm.

Study summary

The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 2 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 or within 4 weeks for immune-oncologic therapy * 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 ≤ 14 days before first dose * 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 4 weeks of the first dose of study drug * History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening * 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 * For combination only: * Prior randomization in a tislelizumab study regardless of the treatment arm, until the primary and key secondary endpoints of the study have read out * Hypersensitivity to tislelizumab or any of its excipients.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Mayo Clinic Scottsdale Arizona
USC/Norris Comprehensive Cancer Center Los Angeles California
Mayo Clinic Jacksonville Florida
Mayo Clinic Rochester Minnesota
Washington University School of Medicine St Louis Missouri
The University of Texas, MD Anderson Cancer Center Houston Texas
NEXT Virginia Cancer Specialists Fairfax Virginia
Hospital Universitario Vall d'Hebron Barcelona Spain
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Clinico Universitario de Valencia Valencia Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05238883 on ClinicalTrials.gov ↗ ← All trials in the USA