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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: Active Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by HiFiBiO Therapeutics.

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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (87% lower). The trial reports 11 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Severity of adverse events will be based on common terminology criteria for adverse events (CTCAE) version 5.0

Conditions Studied

Non-Small Cell Lung Cancer Colorectal Cancer Melanoma Gastric Cancer Renal Cell Carcinoma

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

FieldValue
Enrollment Target 83 participants
Start Date 2023-05-09
Est. Completion 2025-12
Phase Phase 1
HiFiBiO Therapeutics

4 total trials

What the registry record for NCT05789069 still lists

NCT05789069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 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 (87% lower).

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 lists 11 locations in 4 states (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.

Learn More About Clinical Trials

Similar trials for Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05789069's enrollment target sits among peer trials

83 265th of 454 higher than 189 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05789069, the US trial registry maintained by the National Library of Medicine. NCT05789069 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.