Ficlatuzumab

Phase 3Monoclonal antibody

AAVEO Pharmaceuticals, Inc.

Ficlatuzumab is one of 79 biologic programs targeting Refractory Acute Myeloid Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Refractory Acute Myeloid LeukemiaRecruiting

Head and Neck Squamous Cell CarcinomaRecruiting

Refractory Acute Myeloid LeukemiaPreclinical

Recruiting

Head and Neck Squamous Cell CarcinomaPhase 3

Recruiting

Competition

Competitive Landscape

116 competitors in Head and Neck Squamous Cell Carcinoma

#DrugCompanyPhaseTrials

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

35 2

Erbitux

IImclone

Phase 3

28 3

Beyfortus

BeiGene

Phase 3

8 4

Imfinzi

AstraZeneca

Phase 3

6 5

Ibrance

Pfizer

Phase 3

4 6

Taxotere

AAvyxa

Phase 3

16 7

Tuoyi

CCoherus Oncology, Inc.

Phase 3

6 8

Theraplaza

BBiotech Pharmaceutical Co., Ltd.

Phase 3

4 9

Gilotrif

Boehringer Ingelheim

Phase 3

4 10

Jemperli

GGlaxo Dba Glaxosmithkline

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Head and Neck Squamous Cell Carcinoma

NCT06064877

Q4 2032

PreclinicalRecruiting

Refractory Acute Myeloid Leukemia

NCT03013998

Clinical

Trials by Indication[1]

Head and Neck Squamous Cell Carcinoma3 trials

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

Terminated·—·Phase 1·NCT02277184·1 enrolled

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

Recruiting·AAVEO Pharmaceuticals, Inc.·Phase 3·NCT06064877·410 enrolled

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

Completed·JJames J Lee·Phase 1·NCT02277197·14 enrolled

Squamous Cell Carcinoma1 trial

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

Completed·UUniversity of Arizona·Phase 2·NCT03422536·78 enrolled

Pancreatic Cancer1 trial

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

Completed·—·Phase 1·NCT03316599·26 enrolled

Refractory AML1 trial

Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

Terminated·CC. Babis Andreadis·Phase 1·NCT02109627·17 enrolled

Metastatic1 trial

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

Terminated·AAVEO Pharmaceuticals, Inc.·Phase 2·NCT02318368·10 enrolled

3 more indications

Acute Myeloid Leukemia1 trial

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

Withdrawn·AAVEO Pharmaceuticals, Inc.·Phase 2·NCT04100330

ESS1 trial

Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

No longer available·AAVEO Pharmaceuticals, Inc.··NCT02090127

Refractory Acute Myeloid Leukemia1 trial

A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

Recruiting·BBeat AML, LLC·Preclinical·NCT03013998·3,000 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Ficlatuzumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ficlatuzumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ficlatuzumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AVEO Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AAVEO Pharmaceuticals, Inc.

Ficlatuzumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2032

Trials by Indication[1]

Head and Neck Squamous Cell Carcinoma3 trials

Squamous Cell Carcinoma1 trial

Pancreatic Cancer1 trial

Refractory AML1 trial

Metastatic1 trial

Acute Myeloid Leukemia1 trial

ESS1 trial

Refractory Acute Myeloid Leukemia1 trial

References

Drug Info

Quick Facts

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