A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients With Advanced Solid Tumors

  • End date
    Jan 21, 2024
  • participants needed
  • sponsor
    HiFiBiO Therapeutics
Updated on 21 October 2022
systemic therapy
measurable disease
squamous cell carcinoma
lung cancer
lung carcinoma
braf v600e mutation


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.


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

  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.

Condition Gastric Cancer, Renal Cell Carcinoma, Melanoma, Sarcoma, Testicular Germ Cell Tumor, Cervical Cancer, Mesothelioma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Treatment HFB200301
Clinical Study IdentifierNCT05238883
SponsorHiFiBiO Therapeutics
Last Modified on21 October 2022


Yes No Not Sure

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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