Onvansertib

Phase 2Small molecule

CCardiff Oncology

Onvansertib is one of 131 small molecule programs targeting Metastatic Colorectal Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

130

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Colorectal CancerActive, not recruiting

Recurrent Chronic Myelomonocytic LeukemiaRecruiting

Locally Advanced Pancreatic Ductal AdenocarcinomaRecruiting

Pancreatic CancerRecruiting

Small Cell Lung CancerRecruiting

PaclitaxelActive, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Recurrent Chronic Myelomonocytic LeukemiaPhase 1

Recruiting

Locally Advanced Pancreatic Ductal AdenocarcinomaPhase 1

Recruiting

Pancreatic CancerPhase 2

Recruiting

Small Cell Lung CancerPhase 2

Recruiting

PaclitaxelPhase 2

Active, not recruiting

Competition

Competitive Landscape

335 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Onvansertib

CCardiff Oncology

Phase 2

1 2

Byetta

AstraZeneca

Preclinical

1 3

Medrol

Pfizer

Preclinical

1 4

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 7

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 8

Sulfonylureas

Eli Lilly

Preclinical

1 9

Hyperpolarized 13c Pyruvate

UUniversity of Maryland, Baltimore

Preclinical

1 10

PEG-Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Metastatic Colorectal Cancer

NCT06106308

Phase 1/2Recruiting

Pancreatic Cancer

NCT06736717

Q4 2027

Phase 2Recruiting

Small Cell Lung Cancer

NCT05450965

Phase 1Recruiting

Recurrent Chronic Myelomonocytic Leukemia

NCT05549661

Q1 2028

Phase 1Recruiting

Locally Advanced Pancreatic Ductal Adenocarcinoma

NCT04005690

Q1 2029

Phase 1/2Active, not recruiting

Paclitaxel

NCT05383196

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer4 trials

Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

No longer available·CCardiff Oncology··NCT04446793

Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation

Completed·CCardiff Oncology·Phase 1/2·NCT03829410·68 enrolled

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation

Completed·CCardiff Oncology·Phase 2·NCT05593328·23 enrolled

Show 1 more trial

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation

Active, not recruiting·CCardiff Oncology·Phase 2·NCT06106308·113 enrolled

Pancreatic Ductal Adenocarcinoma2 trials

Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma

Withdrawn·OOHSU Knight Cancer Institute·Phase 2·NCT06398587

Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

Completed·CCardiff Oncology·Phase 2·NCT04752696·41 enrolled

Prostate Cancer1 trial

Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer

Completed·CCardiff Oncology·Phase 2·NCT03414034·72 enrolled

Pancreatic Cancer1 trial

Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

Recruiting·UUniversity of Kansas Medical Center·Phase 1/2·NCT06736717·21 enrolled

Paclitaxel1 trial

Onvansertib + Paclitaxel In TNBC

Active, not recruiting·—·Phase 1/2·NCT05383196·50 enrolled

4 more indications

Small Cell Lung Cancer1 trial

Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Recruiting·UUniversity of Maryland, Baltimore·Phase 2·NCT05450965·37 enrolled

Acute Myeloid Leukemia1 trial

Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

Completed·CCardiff Oncology·Phase 1/2·NCT03303339·72 enrolled

Locally Advanced Pancreatic Ductal Adenocarcinoma1 trial

A Window of Opportunity Strategy for Targeted Pathway Inhibition in Patients With Pancreatic Ductal Adenocarcinoma

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04005690·90 enrolled

Recurrent Chronic Myelomonocytic Leukemia1 trial

Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, A Novel, Oral, PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia (CMML) and Myelodysplastic Syndrome/MPN Overlap Neoplasms Relapsed/Refractory or Intolerant to Available Therapies

Recruiting·MMayo Clinic·Phase 1·NCT05549661·25 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Onvansertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Onvansertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Onvansertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Cardiff Oncology company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: CCardiff Oncology

Onvansertib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q1 2028

Q1 2029

Trials by Indication[1]

Metastatic Colorectal Cancer4 trials

Pancreatic Ductal Adenocarcinoma2 trials

Prostate Cancer1 trial

Pancreatic Cancer1 trial

Paclitaxel1 trial

Small Cell Lung Cancer1 trial

Acute Myeloid Leukemia1 trial

Locally Advanced Pancreatic Ductal Adenocarcinoma1 trial

Recurrent Chronic Myelomonocytic Leukemia1 trial

References

Drug Info

Quick Facts

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