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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 10 study locations across 8 states.

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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

Non-Small Cell Lung Cancer Melanoma Gastric Cancer Cervical Cancer Sarcoma Head and Neck Squamous Cell Carcinoma Renal Cell Carcinoma Mesothelioma Testicular Germ Cell Tumor

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

FieldValue
Enrollment Target 72 participants
Start Date 2022-03-10
Est. Completion 2026-12
Phase Phase 1

Sponsor

HiFiBiO Therapeutics

4 total trials

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What the Registry Record Tells You About NCT05238883

The ClinicalTrials.gov registry entry for NCT05238883 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 72 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 (89% lower). The listed sponsor is HiFiBiO Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.