NCT05222165 (NEWEL) is a Phase 1, PHASE2 clinical trial of Infigratinib in Advanced Solid Tumor, sponsored by Helsinn Healthcare SA.

Who is sponsoring NCT05222165?

NCT05222165 is sponsored by Helsinn Healthcare SA.

What drugs are being tested in NCT05222165?

Interventions in NCT05222165: Infigratinib.

What condition does NCT05222165 study?

NCT05222165 studies Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma.

Is NCT05222165 still recruiting?

NCT05222165 is currently withdrawn. Last updated 23 February 2023.

Last reviewed 2023-02-23 · How we verify

NCT05222165: NEWEL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

Withdrawn Phase 1, PHASE2 Last updated 23 February 2023

What this trial tests

Phase 1, PHASE2 trial testing Infigratinib in Advanced Solid Tumor. Withdrawn.

Timeline

1 October 2021

Primary endpoint
16 December 2022

16 December 2022

Quick facts

Lead sponsor	Helsinn Healthcare SA
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 October 2021
Primary completion	16 December 2022
Estimated completion	16 December 2022
Sites	10 locations across Canada, United States, Germany

Drugs / interventions tested

Infigratinib (INFIGRATINIB) — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
CNS Tumor — all drugs for CNS Tumor →
Recurrent WHO Grade II Glioma — all drugs for Recurrent WHO Grade II Glioma →

Sponsor

Helsinn Healthcare SA — full company profile →

Who can join

3 and older, any sex, with Advanced Solid Tumor or CNS Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The phase 1b study is aimed at determining the pediatric recommended phase 2 dose (RP2D) of Infigratinib. The phase 2 study will evaluate efficacy and safety of infigratinib.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

FGFR3-TACCs3 Fusions and Their Clinical Relevance in Human Glioblastoma.
Gött H, Uhl E. · · 2022 · cited 16× · PMID 35955806 · DOI 10.3390/ijms23158675
Rare FGFR Oncogenic Alterations in Sequenced Pediatric Solid and Brain Tumors Suggest FGFR Is a Relevant Molecular Target in Childhood Cancer.
Lazo De La Vega L, Comeau H, Sallan S, Al-Ibraheemi A, et al · · 2022 · cited 14× · PMID 36446043 · DOI 10.1200/po.22.00390
Slipped capital femoral epiphyses: A major on-target adverse event associated with FGFR tyrosine kinase inhibitors in pediatric patients.
Farouk Sait S, Fischer C, Antal Z, Spatz K, et al · · 2023 · cited 9× · PMID 37158537 · DOI 10.1002/pbc.30410
Tumor Microenvironment in Gliomas: A Treatment Hurdle or an Opportunity to Grab?
Di Nunno V, Aprile M, Gatto L, Tosoni A, et al · · 2023 · cited 8× · PMID 36831383 · DOI 10.3390/cancers15041042
RNA fusion transcript panel identifies diverse repertoire of fusions in adult glioma patients with therapeutic implications.
Kothari S, Dusenbery AC, Doucette A, Zhang DY, et al · · 2023 · cited 3× · PMID 37457221 · DOI 10.1093/nop/npad022
Landscape of targeted therapies for advanced urothelial carcinoma.
Shang S, Zhang L, Liu K, Lv M, et al · · 2024 · cited 2× · PMID 38966172 · DOI 10.37349/etat.2024.00240

Verify or expand the search:

Other trials of Infigratinib

Trials testing the same drug.

NCT07393373 — Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia · Phase 2 · enrolling by invitation
NCT06206278 — Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma · Phase 2 · terminated
NCT05510427 — Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advance · Phase 1 · withdrawn
NCT05145010 — Extension Study of Infigratinib in Children With Achondroplasia (ACH) · Phase 2 · enrolling by invitation
NCT04504331 — Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced B · Phase 1 · terminated

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting

Other Helsinn Healthcare SA trials

Trials by the same sponsor.

NCT06840769 — A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteers · Phase 1 · terminated
NCT04817189 — Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) · Phase 4 · completed
NCT03743064 — A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and · Phase 3 · completed
NCT03743051 — A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and · Phase 3 · completed
NCT03403712 — A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05222165 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Helsinn Healthcare SA
Last refreshed: 23 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05222165.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing