Ficlatuzumab

DRUG10 trials

Conditions

Acute Myeloid LeukemiaCarcinoma, Squamous Cell of Head and NeckHNSCCHead and Neck Basaloid CarcinomaHead and Neck CancerHead and Neck Squamous Cell Carcinoma (HNSCC)Metastatic Head-and-neck Squamous-cell CarcinomaMullerian Mixed Tumor of Ovary

Phase 1

Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

TerminatedNCT02109627

C. Babis AndreadisAcute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia

Start: 2015-05-01End: 2019-12-02Updated: 2020-03-24

Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma

TerminatedNCT02277184

Julie E. Bauman, MD, MPHCarcinoma, Squamous Cell of Head and Neck

Start: 2015-09-30End: 2016-09-30Updated: 2017-11-13

Ficlatuzumab and Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

CompletedNCT02277197

James J LeeCarcinoma, Squamous Cell of Head and Neck, Squamous Cell Carcinoma, Head And Neck, Squamous Cell Carcinoma of the Head and Neck

Start: 2015-08-31End: 2018-02-28Updated: 2019-04-18

Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer

CompletedNCT03316599

Dana-Farber Cancer InstitutePancreatic Cancer

Start: 2018-01-17End: 2021-07-29Updated: 2021-08-03

Phase 2

A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

TerminatedNCT02318368

AVEO Pharmaceuticals, Inc.Non-small Cell Lung Cancer

Start: 2014-11-30End: 2017-01-31Updated: 2020-10-22

Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma

CompletedNCT03422536

University of ArizonaHead and Neck Basaloid Carcinoma, Head and Neck Cancer, HNSCC +21

Start: 2017-12-05End: 2022-04-05Updated: 2024-09-04

A Study of Ficlatuzumab With HiDAC and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia

WithdrawnNCT04100330

AVEO Pharmaceuticals, Inc.Acute Myeloid Leukemia

Start: 2020-01-31End: 2020-03-27Updated: 2020-03-31

Phase 3

A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

RecruitingNCT06064877

AVEO Pharmaceuticals, Inc.Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma

Start: 2024-01-11End: 2027-11-30Target: 410Updated: 2025-04-13

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Participants with Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN)

RecruitingCTIS2023-505606-42-00

Aveo Pharmaceuticals Inc.Head and Neck Squamous Cell Carcinoma (HNSCC)

Start: 2024-10-15Target: 204Updated: 2025-05-17

Unknown Phase

Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

NCT02090127

AVEO Pharmaceuticals, Inc.Mullerian Mixed Tumor of Ovary

Updated: 2015-07-29

Blood2025-11-03

FIERCE-HN: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of ficlatuzumab (HGF/cMET MAb) in combination with cetuximab in participants with recurrent or metastatic (R/M) HPV negative head and neck squamous cell carcinoma (HNSCC).

Journal of Clinical Oncology2025-05-28

Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).

Journal of Clinical Oncology2021-05-207 citations

Analysis of Multiplexed Single Cell RNA Sequencing Clinical Correlative Data in AML Reveals Biomarkers of Resistance

Blood2020-11-042 citations

Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Journal of Clinical Oncology2020-05-20

Phase Ib study of gemcitabine, nab-paclitaxel, and ficlatuzumab in patients with advanced pancreatic cancer.

Journal of Clinical Oncology2020-02-014 citations

Abstract 2957: Sequential transcriptomic and phosphorylation landscape of acute myelogenous leukemia (AML) on the single-cell level

Cancer Research2018-07-01

Phase 1b study of gemcitabine, nab-paclitaxel, and ficlatuzumab in patients with advanced pancreatic cancer.

Journal of Clinical Oncology2018-05-201 citations

Phase I study of the anti-HGF monoclonal antibody (mAb), ficlatuzumab, and cetuximab in cetuximab-resistant, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Journal of Clinical Oncology2017-05-202 citations

CyFi: A phase I study exploring the role of cMET pathway inhibition with ficlatuzumab (Fi) combined with high-dose cytarabine (Cy) in patients with high risk relapsed or refractory acute myeloid leukemia (AML).

Journal of Clinical Oncology2017-05-20