A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors
3 other identifiers
interventional
72
2 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 gastric-cancer
Started Mar 2022
Typical duration for phase_1 gastric-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 21, 2025
November 1, 2025
4.7 years
December 16, 2021
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity)
assessed up to 3 years
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
assessed up to 3 years
Secondary Outcomes (9)
Objective Response Rate (ORR)
assessed up to 3 years
Disease Control Rate (DCR)
assessed up to 3 years
Duration of Response (DOR)
assessed up to 3 years
Progression Free Survival (PFS)
assessed up to 3 years
Maximum serum concentration (Cmax)
average of 3 years
- +4 more secondary outcomes
Study Arms (4)
Dose Escalation - HFB200301 monotherapy
EXPERIMENTALParticipants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Dose Escalation - HFB200301 in combination with tislelizumab
EXPERIMENTALParticipants will be administered HFB200301 at dose levels 1-4 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Dose for Expansion (RDE).
Dose Expansion - HFB200301 monotherapy
EXPERIMENTALParticipants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.
Dose Expansion - HFB200301 in combination with tislelizumab
EXPERIMENTALParticipations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.
Interventions
Participants will be administered HFB200301 as described in the experimental arm.
Participants will be administered tislelizumab as described in the experimental arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
St 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
Related Publications (1)
Gao Z, Zhang Q, Chen H, Chen J, Kang J, Yu H, Song Y, Zhang X. TNFR2 promotes pancreatic cancer proliferation, migration, and invasion via the NF-kappaB signaling pathway. Aging (Albany NY). 2023 Aug 16;15(16):8013-8025. doi: 10.18632/aging.204941. Epub 2023 Aug 16.
PMID: 37589506DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2021
First Posted
February 14, 2022
Study Start
March 10, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 21, 2025
Record last verified: 2025-11