A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients With Advanced Solid Tumors
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- STATUS
- Recruiting
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- End date
- Jan 21, 2024
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- participants needed
- 90
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- sponsor
- HiFiBiO Therapeutics
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.
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.
Details
| 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 Identifier | NCT05238883 |
| Sponsor | HiFiBiO Therapeutics |
| Last Modified on | 21 October 2022 |
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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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