Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
NCT05789069 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HiFiBiO Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which Tislelizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05789069 reports 11 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Colorectal Cancer, Melanoma, Gastric Cancer, Non Small Cell Lung Cancer, Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05789069?
The interventions under investigation include: Tislelizumab (DRUG), HFB200603 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05789069?
This trial is sponsored by HiFiBiO Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.