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NCT05238883 · ClinicalTrials.gov registry record · Phase 1
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by HiFiBiO Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 10
- Study locations
NCT05238883: Active Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by HiFiBiO Therapeutics.
NCT05238883 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is active but no longer recruiting, run by HiFiBiO Therapeutics. The registered enrollment target is 72 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05238883, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is active but no longer recruiting, sponsored by HiFiBiO Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 10
- Study locations
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.
Conditions Studied
Interventions
- DRUG Tislelizumab
- DRUG HFB200301
Study Locations (10)
Other
- Hospital Universitario Vall d'Hebron - Barcelona
- Hospital Universitario 12 de Octubre - Madrid
- Hospital Clinico Universitario de Valencia - Valencia
Arizona
- Mayo Clinic - Scottsdale
California
- USC/Norris Comprehensive Cancer Center - Los Angeles
Florida
- Mayo Clinic - Jacksonville
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University School of Medicine - St Louis
Texas
- The University of Texas, MD Anderson Cancer Center - Houston
Virginia
- NEXT Virginia Cancer Specialists - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT05238883 still lists
NCT05238883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower).
The record links to 9 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Tislelizumab is the first listed.
NCT05238883 lists 10 locations in 8 states (Other, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT05238883 about?
NCT05238883 is a clinical study titled "A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors". 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 ...
What is the current status of trial NCT05238883?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2022-03-10. Estimated completion is 2026-12.
What conditions does trial NCT05238883 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Gastric Cancer, Cervical Cancer, Sarcoma.
What interventions are being tested in trial NCT05238883?
The interventions under investigation include: Tislelizumab (DRUG), HFB200301 (DRUG).
Who is sponsoring clinical trial NCT05238883?
This trial is sponsored by HiFiBiO Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05238883 being conducted?
This trial has 10 study locations across Arizona, California, Florida, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05238883's enrollment target sits among peer trials
72 284th of 454 higher than 170 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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