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NCT05789069 · ClinicalTrials.gov registry record · Phase 1
A Study of HFB200603 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 Colorectal Cancer, sponsored by HiFiBiO Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 11
- Study locations
NCT05789069 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is active but no longer recruiting, run by HiFiBiO Therapeutics. The registered enrollment target is 83 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (87% lower). The trial reports 11 study locations across 4 states.
The verdict
NCT05789069, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is active but no longer recruiting, sponsored by HiFiBiO Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to test the safety and tolerability of HFB200603 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 HFB200603 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200603 as a single agent or combination therapy is determined. During the expansion part, participants will take the doses of HFB200603 as a monotherapy (optional arm) or in combination with tislelizumab that were 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 HFB200603
Study Locations (11)
Other
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Naples
- UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore - Rome
- Centro Ricerche Cliniche di Verona s.r.l. - Verona
- Clinica Universidad de Navarra - Madrid - Madrid
- South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz - Madrid
- South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC - Madrid
- Clinica Universidad de Navarra - Pamplona - Pamplona
- Hospital Clinico Universitario de Valencia - Valencia
California
- USC Norris Comprehensive Cancer Center - Los Angeles
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Virginia
- New Experimental Therapeutics of Virginia - NEXT Oncology - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2023-05-09 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05789069
The ClinicalTrials.gov registry entry for NCT05789069 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (87% lower). The listed sponsor is HiFiBiO Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Tislelizumab is the first listed.
NCT05789069 reports 11 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05789069 about?
NCT05789069 is a clinical study titled "A Study of HFB200603 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 HFB200603 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 HFB200603 as ...
What is the current status of trial NCT05789069?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2023-05-09. Estimated completion is 2025-12.
What conditions does trial NCT05789069 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Melanoma, Gastric Cancer, Renal Cell Carcinoma.
What interventions are being tested in trial NCT05789069?
The interventions under investigation include: Tislelizumab (DRUG), HFB200603 (DRUG).
Who is sponsoring clinical trial NCT05789069?
This trial is sponsored by HiFiBiO Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05789069 being conducted?
This trial has 11 study locations across California, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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