NCT05325866 (FORTITUDE-301) is a Phase 1, PHASE2 clinical trial of Bemarituzumab in Solid Tumors, sponsored by Amgen.

Who is sponsoring NCT05325866?

NCT05325866 is sponsored by Amgen.

What drugs are being tested in NCT05325866?

Interventions in NCT05325866: Bemarituzumab.

What condition does NCT05325866 study?

NCT05325866 studies Solid Tumors.

Is NCT05325866 still recruiting?

NCT05325866 is currently completed. Last updated 4 February 2026.

Last reviewed 2026-02-04 · How we verify

NCT05325866: FORTITUDE-301

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

A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Completed Phase 1, PHASE2 Last updated 4 February 2026

What this trial tests

Phase 1, PHASE2 trial testing Bemarituzumab in Solid Tumors in 260 participants. Completed in 28 January 2026.

Timeline

23 September 2022

Primary endpoint
28 January 2026

28 January 2026

Quick facts

Lead sponsor	Amgen
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	260
Start date	23 September 2022
Primary completion	28 January 2026
Estimated completion	28 January 2026
Sites	115 locations across Italy, Finland, Japan, Poland, South Korea, Denmark, Netherlands, Belgium

Drugs / interventions tested

Bemarituzumab — full drug profile →

Conditions studied

Solid Tumors — all drugs for Solid Tumors →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 99, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

Publications & conference data

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

Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
Angiogenesis and targeted therapy in the tumour microenvironment: From basic to clinical practice.
Yang S, Fang Y, Ma Y, Wang F, et al · · 2025 · cited 22× · PMID 40268524 · DOI 10.1002/ctm2.70313
Therapeutic Targeting of FGFR Signaling in Head and Neck Cancer.
Wang Z, Anderson KS. · · 2022 · cited 22× · PMID 36165723 · DOI 10.1097/ppo.0000000000000615
Newest Therapies for Cholangiocarcinoma: An Updated Overview of Approved Treatments with Transplant Oncology Vision.
Zhang Y, Esmail A, Mazzaferro V, Abdelrahim M. · · 2022 · cited 20× · PMID 36291857 · DOI 10.3390/cancers14205074
Molecular Targeting of the Fibroblast Growth Factor Receptor Pathway across Various Cancers.
Shan KS, Dalal S, Thaw Dar NN, McLish O, et al · · 2024 · cited 16× · PMID 38255923 · DOI 10.3390/ijms25020849
Monoclonal antibodies that target fibroblast growth factor receptor 2 isoform b and Claudin-18 isoform 2 splicing variants in gastric cancer and other solid tumours.
Katoh M, Nakayama I, Wainberg ZA, Shitara K, et al · · 2024 · cited 6× · PMID 38877656 · DOI 10.1002/ctm2.1736
Emerging Tumor-Agnostic Molecular Targets.
Bhamidipati D, Schram AM. · · 2024 · cited 3× · PMID 39279103 · DOI 10.1158/1535-7163.mct-23-0725
Basket trials in rare diseases: a systematic review of current practices, methodological challenges, and future directions.
Khazen W, Corriol-Rohou S, Evangelista T, Valent A, et al · · 2025 · cited 1× · PMID 41225614 · DOI 10.1186/s13023-025-04048-w

Verify or expand the search:

Other trials of Bemarituzumab

Trials testing the same drug.

NCT07470840 — SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma · Phase 2 · not yet recruiting
NCT06978062 — Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment · Phase 1 · not yet recruiting
NCT07146919 — AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer · Phase 1, PHASE2 · not yet recruiting
NCT05322577 — A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated A · Phase 1, PHASE2 · active not recruiting
NCT05267470 — A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpressio · Phase 1 · terminated

Other recruiting trials for Solid Tumors

Currently open trials in the same condition.

NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · 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 NCT05325866 (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 Amgen
Last refreshed: 4 February 2026

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/NCT05325866.

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