Clinical trials: Fibroblast Growth Factor Receptor
Solid Tumors
An Open-label Phase I Study of Orally Available Novel Small-molecule Fibroblast Growth Factor Receptors (FGFR) 1,2,3 and 4 Inhibitor, ASP5878 at Single and Multiple Doses in Patients With Solid Tumors
The objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors.
- Trial name
- NCT02038673
- Testing
- ASP5878
- Where
- 35 sites in United States, Japan and 2 more
- Volunteers
- 86 people
- Sponsor
- Astellas Pharma Inc
Neoplasms
Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)
This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor.
- Trial name
- NCT01976741
- Testing
- Rogaratinib (BAY1163877) oral solution, Rogaratinib (BAY1163877) oral tablet, Rogaratinib (BAY1163877) 800 mg BID
- Where
- 29 sites in United States, France and 5 more
- Volunteers
- 168 people
- Sponsor
- Bayer
Urothelial Carcinoma
A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC
This trial is an open, phase II clinical study. The study is divided into two parts: A and B, and the part A evaluate the safety and tolerability of AZD4547 combined with Tislelizumab in patients with locally advanced or…
- Trial name
- NCT05775874
- Testing
- AZD4547, Tislelizumab
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Neoplasm
A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma
The primary purpose of this study is to evaluate objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a molecularly-defined subset of Asian participants with…
- Trial name
- NCT02699606
- Testing
- Erdafitinib
- Where
- 6 sites in China, South Korea and 1 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Neoplasms, Lymphoma
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Patients With Advanced or Refractory Solid Tumors or Lymphoma
The purpose of this study is to determine a dose for future development and to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy profiles of JNJ-42756493 in Japanese and other Asian patients with advanced or…
- Conditions
- Neoplasms, Lymphoma, Adenocarcinoma, Esophagogastric Junction
- Trial name
- NCT01962532
- Testing
- Part 1: JNJ-42756493, Part 2: JNJ-42756493
- Where
- 3 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Janssen Research & Development, LLC
Urothelial Carcinoma
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic…
- Trial name
- FIDES-02 (NCT04045613)
- Testing
- Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg, Derazantinib 300 mg once daily+ atezolizumab 1200 mg
- Where
- 66 sites in United States, Australia and 12 more
- Volunteers
- 95 people
- Sponsor
- Basilea Pharmaceutica
Urinary Bladder Neoplasms, Neoplasm Metastasis
Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
- Conditions
- Urinary Bladder Neoplasms, Neoplasm Metastasis, Carcinoma, Transitional Cell
- Trial name
- NCT07675057
- Testing
- Vepugratinib
- Sponsor
- Eli Lilly and Company
Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma
Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not…
- Trial name
- NCT04003610
- Testing
- Pemigatinib, Pembrolizumab, Gemcitabine
- Where
- 79 sites in United States, Austria and 14 more
- Volunteers
- 7 people
- Sponsor
- Incyte Corporation
Solid Tumors
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.
- Trial name
- FORTITUDE-301 (NCT05325866)
- Testing
- Bemarituzumab
- Where
- 115 sites in United States, Argentina and 24 more
- Volunteers
- 260 people
- Sponsor
- Amgen
Solid Tumours
Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1…
- Trial name
- NCT01948297
- Testing
- Debio1347 (CH5183284)
- Where
- 8 sites in United States, Singapore and 3 more
- Volunteers
- 77 people
- Sponsor
- Debiopharm International SA
Gastric Adenocarcinoma
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e.
- Trial name
- FIDES-03 (NCT04604132)
- Testing
- Derazantinib, Derazantinib-paclitaxel-ramucirumab combination
- Where
- 81 sites in United States, Argentina and 13 more
- Volunteers
- 47 people
- Sponsor
- Basilea Pharmaceutica
Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
- Trial name
- TAR-210 (NCT05567185)
- Testing
- Erdafitinib Intravesical Delivery System
- Where
- 4 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Janssen Pharmaceutical K.K.
Advanced or Metastatic Solid Tumor
Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors
The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally…
- Trial name
- ROCOCO (NCT03517956)
- Testing
- Rogaratinib (BAY1163877), Copanlisib (BAY80-6946)
- Where
- 20 sites in United States, Belgium and 4 more
- Volunteers
- 16 people
- Sponsor
- Bayer
Urothelial Cancer, Receptors, Fibroblast Growth Factor
A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.
- Trial name
- NCT03955913
- Testing
- Archival Tumor Tissue Sample
- Where
- 199 sites in United States, Argentina and 12 more
- Volunteers
- 3,679 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Breast Cancer, FGFR 1 High Amplification
A Study of TAS-120 in Patients With Metastatic Breast Cancer
The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant.
- Conditions
- Metastatic Breast Cancer, FGFR 1 High Amplification, FGFR2 Amplification
- Trial name
- NCT04024436
- Testing
- Futibatinib, Futibatinib plus Fulvestrant
- Where
- 37 sites in United States, Canada and 5 more
- Volunteers
- 64 people
- Sponsor
- Taiho Oncology, Inc.
Achondroplasia
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants < 3 years old with ACH.
- Trial name
- NCT07169279
- Testing
- Infigratinib is provided as a single dose of minitablets for oral administration, Infigratinib is provided as sprinkle capsules for daily oral administration
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Advanced Cancers and FGFR Genetic Alterations
Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options
The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration [FDA] approval in the United States).
- Trial name
- NCT03825484
- Testing
- Erdafitinib
- Sponsor
- Janssen Scientific Affairs, LLC
Medical Oncology
Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)
To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth…
- Trial name
- NCT02368951
- Testing
- BAY1187982
- Where
- 13 sites in United States, Singapore and 1 more
- Volunteers
- 20 people
- Sponsor
- Bayer
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
- Conditions
- Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms
- Trial name
- NCT02834780
- Testing
- H3B-6527
- Where
- 44 sites in United States, Belgium and 9 more
- Volunteers
- 128 people
- Sponsor
- H3 Biomedicine Inc.