NCT04258527 is a Phase 1 clinical trial of Pemigatinib in Solid Tumor, sponsored by Innovent Biologics (Suzhou) Co. Ltd..

Who is sponsoring NCT04258527?

NCT04258527 is sponsored by Innovent Biologics (Suzhou) Co. Ltd..

What drugs are being tested in NCT04258527?

Interventions in NCT04258527: Pemigatinib.

What condition does NCT04258527 study?

NCT04258527 studies Solid Tumor.

Is NCT04258527 still recruiting?

NCT04258527 is currently completed. Last updated 23 July 2021.

Last reviewed 2021-07-23 · How we verify

NCT04258527

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

Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

Completed Phase 1 Last updated 23 July 2021

What this trial tests

Phase 1 trial testing Pemigatinib in Solid Tumor in 12 participants. Completed in 8 March 2021.

Timeline

26 March 2020

Primary endpoint
2 July 2020

8 March 2021

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	26 March 2020
Primary completion	2 July 2020
Estimated completion	8 March 2021
Sites	1 location across China

Drugs / interventions tested

Pemigatinib (PEMIGATINIB) — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. — full company profile →

Who can join

18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.

Publications & conference data

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

FGFR-TKI resistance in cancer: current status and perspectives.
Yue S, Li Y, Chen X, Wang J, et al · · 2021 · cited 98× · PMID 33568192 · DOI 10.1186/s13045-021-01040-2
FGFR Fusions in Cancer: From Diagnostic Approaches to Therapeutic Intervention.
De Luca A, Esposito Abate R, Rachiglio AM, Maiello MR, et al · · 2020 · cited 87× · PMID 32962091 · DOI 10.3390/ijms21186856
FGFR4: A promising therapeutic target for breast cancer and other solid tumors.
Levine KM, Ding K, Chen L, Oesterreich S. · · 2020 · cited 68× · PMID 32492514 · DOI 10.1016/j.pharmthera.2020.107590
Fibroblast growth factor receptor fusions in cancer: opportunities and challenges.
Chen L, Zhang Y, Yin L, Cai B, et al · · 2021 · cited 50× · PMID 34732230 · DOI 10.1186/s13046-021-02156-6
Targeted Therapies in Advanced Cholangiocarcinoma: A Focus on FGFR Inhibitors.
Rizzo A. · · 2021 · cited 12× · PMID 34066684 · DOI 10.3390/medicina57050458
Systemic Treatment for Metastatic Biliary Tract Cancer: State of the Art and a Glimpse to the Future.
Rizzo A, Ricci AD, Cusmai A, Acquafredda S, et al · · 2022 · cited 6× · PMID 35200550 · DOI 10.3390/curroncol29020050
Intrahepatic Cholangiocarcinoma: State of the Art of FGFR Inhibitors.
Wu T, Jiang X, Zhang X, Wu B, et al · · 2021 · cited 6× · PMID 33618536 · DOI 10.1177/1073274821989314
Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial.
Deng T, Zhang L, Shi Y, Bai G, et al · · 2023 · cited 3× · PMID 37889382 · DOI 10.1007/s10637-023-01396-x

Verify or expand the search:

Other trials of Pemigatinib

Trials testing the same drug.

NCT06906562 — A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metasta · Phase 2 · recruiting
NCT06653777 — Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells · Phase 2 · recruiting
NCT06439485 — Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarc · Phase 1, PHASE2 · recruiting
NCT06551896 — Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor · Phase 2 · not yet recruiting
NCT06389799 — A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) · Phase 2 · recruiting

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Innovent Biologics (Suzhou) Co. Ltd. trials

Trials by the same sponsor.

NCT07502534 — A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers · Phase 1 · not yet recruiting
NCT07469800 — Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity · Phase 3 · not yet recruiting
NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
NCT07483567 — IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastri · Phase 2 · not yet recruiting
NCT07483554 — IBI343 in Combination Therapy for Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting

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 NCT04258527 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Innovent Biologics (Suzhou) Co. Ltd.
Last refreshed: 23 July 2021

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/NCT04258527.

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