Drugs / Onvansertib
Onvansertib
also known as
NMS-1286937 · NMS-P937 · Nms-p937 fumarate · Nms-p937 fumarate salt · ONVANSERTIB FUMARATE · PCM-075 · Pcm-075 fumarate · PMS-075H
Small molecule targets PLK1 via inhibition
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04005690 | Aug 2019 → Jun 2027 expected | pancreatic ductal adenocarcinoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05549661 | Apr 2023 → Jun 2027 expected | atypical chronic myeloid leukemia, BCR-ABL1 negative, chronic myelomonocytic leukemia | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT01014429 | Nov 2009 → Oct 2011 | — | Nerviano Medical Sciences | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06736717 | Feb 2025 → Jul 2026 overdue | malignant pancreatic neoplasm | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05383196 | Sep 2022 → Dec 2026 expected | inflammatory breast carcinoma, triple-negative breast carcinoma | Antonio Giordano, MD | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03829410 | Jun 2019 → Jan 2024 | colorectal cancer | Cardiff Oncology | Completed | No outcome recorded |
| Phase 1/2 | NCT03303339 | Nov 2017 → Nov 2021 | acute myeloid leukemia | Cardiff Oncology | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT06398587 | Aug 2024 → May 2026 | pancreatic ductal adenocarcinoma | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT06106308 | Feb 2024 → Nov 2026 expected | colorectal cancer | Cardiff Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05593328 | Mar 2023 → Dec 2024 | colorectal cancer | Cardiff Oncology | Completed | No outcome recorded |
| Phase 2 | NCT05450965 | Jul 2022 → Aug 2027 expected | small cell lung carcinoma | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 2 | NCT04752696 | May 2021 → Dec 2024 | pancreatic ductal adenocarcinoma | Cardiff Oncology | Completed | No outcome recorded |
| Phase 2 | NCT03414034 | Aug 2018 → Oct 2023 | prostate carcinoma | Cardiff Oncology | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT04446793 | — | colorectal cancer | Cardiff Oncology | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Cardiff Oncology | Results Cardiff Oncology Announces Presentation of Positive Results from its Randomized, Controlled Phase 2 Trial of Onvansertib in First-Line RAS-Mutated mCRC at the 2026 ASCO Annual Meeting cardiffoncology.com ↗
30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC |
| 2026-04-17 | Cardiff Oncology | Results Cardiff Oncology Presents Preclinical Data on its PLK1 Inhibitor Onvansertib in Combination with a HER2-Targeted ADC at the 2026 AACR Annual Meeting cardiffoncology.com ↗
Onvansertib in combination with trastuzumab deruxtecan demonstrated enhanced antitumor activity, including tumor regression and apoptosis in HER2-low breast cancer models, supporting its potential for patients with limited treatment options |
| 2026-03-19 | Cardiff Oncology | Results Cardiff Oncology to Present Preclinical Data with Highly Specific PLK1 Inhibitor Onvansertib at the 2026 AACR Annual Meeting cardiffoncology.com ↗
The poster presentation will showcase findings demonstrating that onvansertib enhanced the antitumor activity of T-DXd and reversed resistance in therapy-resistant HER2-low breast cancer models. |
| 2026-01-27 | Cardiff Oncology | Results Cardiff Oncology Announces Positive Update from its Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC cardiffoncology.com ↗
In an intent-to-treat analysis, the clinical data show dose-dependent benefits across multiple efficacy measures in patients receiving onvansertib with FOLFIRI/bev compared to patients receiving either SoC regimen. |
| 2025-12-08 | Cardiff Oncology | Results Cardiff Oncology Announces Clinical Data from Investigator-Sponsored Trial with Onvansertib in Chronic Myelomonocytic Leukemia at ASH 2025 cardiffoncology.com ↗
These results, along with previously announced data from an investigator-sponsored trial in small cell lung cancer, validate onvansertib’s single agent activity in both hematologic and solid tumors. |
| 2025-07-29 | Cardiff Oncology | Results Cardiff Oncology Announces Positive Data from Ongoing Randomized Phase 2 First-line RAS-mutated mCRC Clinical Trial (CRDF-004) cardiffoncology.com ↗
Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive data from the ongoing CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). |
| 2025-06-02 | Cardiff Oncology | Results Cardiff Oncology Announces Positive Data from Investigator-Initiated Trial of Onvansertib in Combination with Paclitaxel in Metastatic Triple-Negative Breast Cancer Presented at ASCO 2025 cardiffoncology.com ↗
Additionally, we observed a dose-response relationship, with the highest dose of onvansertib resulting in a 40% objective response rate. |
| 2024-12-10 | Cardiff Oncology | Results Cardiff Oncology Announces Positive Initial Data from First-line RAS-mutated mCRC Clinical Trial cardiffoncology.com ↗
Onvansertib was well tolerated at both doses |
| 2024-10-30 | Cardiff Oncology | Results Cardiff Oncology Announces Journal of Clinical Oncology Publication of Data from Phase 2 Trial in Second-line KRAS Mutant mCRC cardiffoncology.com ↗
Post hoc analysis resulted in a 7.7-fold higher clinical benefit in bev-naïve patients with an ORR of 77% compared to 10% in bev-exposed patients |
| 2024-02-29 | Cardiff Oncology | Results Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update cardiffoncology.com ↗
New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients |
| 2024-02-29 | Cardiff Oncology | Results Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC cardiffoncology.com ↗
The only objective responses observed on the trial occurred in bev naïve patients who received onvansertib plus standard of care, and the combination of onvansertib with standard of care was well-tolerated. |
| 2024-01-17 | Cardiff Oncology | Results Cardiff Oncology Announces Publication of Data from Phase 1b study in second-line KRAS-mutated mCRC in Clinical Cancer Research cardiffoncology.com ↗
The results show that the combination has a lasting response, indicating its tolerability and efficacy in treating mCRC patients whose tumors harbor various KRAS mutations. |
| 2023-09-26 | Cardiff Oncology | Results Cardiff Oncology Announces Positive Clinical Data in Pancreatic Cancer and Small Cell Lung Cancer, including Single-Agent Activity from Onvansertib Monotherapy cardiffoncology.com ↗
Preliminary data from small cell lung cancer Phase 2 trial in refractory patients with extensive stage disease demonstrate single-agent activity from onvansertib monotherapy |
| 2022-09-12 | Cardiff Oncology | Results Cardiff Oncology Announces Plans for a Randomized Trial in Metastatic Colorectal Cancer (mCRC), Durability of Responses in Ongoing Phase 1b/2 Trial in mCRC and Additional Business Updates cardiffoncology.com ↗
Data from ongoing Phase 1b/2 trial in KRAS-mutated mCRC show durable responses to treatment, with a median duration of response (mDoR) of 11.7 months for all doses and 12.5 months for the recommended phase 2 dose |
| 2022-09-10 | Cardiff Oncology | Results Cardiff Oncology Announces New Preclinical and Clinical Data from Program in KRAS-mutated Metastatic Colorectal Cancer (mCRC) at the ESMO Congress 2022 cardiffoncology.com ↗
Patients with a ≥90% decrease in KRAS mutant allele frequency (MAF), a response biomarker, in the first cycle of treatment had significantly higher ORR and longer PFS in Phase 1b/2 trial and an Expanded Access Program (EAP) |
| 2022-09-06 | Cardiff Oncology | Results Cardiff Oncology Announces Upcoming Poster Presentations at the ESMO Congress 2022 cardiffoncology.com ↗
These findings showed that early changes in KRAS mutant allelic frequency (MAF) were associated with increased benefit in the EAP. |
| 2022-05-05 | Cardiff Oncology | Results Cardiff Oncology Reports First Quarter 2022 Results and Provides Business Updates cardiffoncology.com ↗
Results from the trial, which were presented in a poster at the American Association for Cancer Research (AACR) Annual Meeting, showed clinically meaningful disease control rates that rose with increasing onvansertib dose density. |
| 2022-04-08 | Cardiff Oncology | Results Cardiff Oncology Announces Updated Clinical and New Biomarker Data from Phase 2 Metastatic Castration-Resistant Prostate Cancer Trial at the AACR Annual Meeting cardiffoncology.com ↗
Median progression-free survival (mPFS) has increased with increasing onvansertib dose density from 4.1 months in Arm A to 13.2 months to-date in Arm C patients |
| 2022-04-08 | Cardiff Oncology | Results Cardiff Oncology Announces Data Showing the Combination of PARP Inhibition with Onvansertib Overcomes PARP Inhibitor Resistance in BRCA1-mutant and Wildtype Patient-Derived Xenograft Ovarian Cancer Models cardiffoncology.com ↗
Combining onvansertib with the PARP inhibitor (PARPi) olaparib led to statistically significant survival benefits compared to treatment with either agent alone in PARPi-resistant ovarian cancer models |
| 2022-03-08 | Cardiff Oncology | Results Cardiff Oncology Announces Upcoming Poster Presentations at the AACR Annual Meeting cardiffoncology.com ↗
This abstract includes preclinical data that demonstrate the potent anti-tumor activity of onvansertib combined with the PARP inhibitor olaparib in olaparib-resistant ovarian cancer models. |
| 2022-01-18 | Cardiff Oncology | Results Cardiff Oncology Announces New Data from Lead Clinical Program in KRAS-mutated Metastatic Colorectal Cancer Showing Robust Objective Response Rate and Progression Free Survival cardiffoncology.com ↗
12 of 35 (34%) patients treated per protocol at the recommended Phase 2 dose (RP2D) in combination with FOLFIRI and bevacizumab achieved a complete response or partial response (CR: 1 patient; PR: 11 patients) |
| 2021-09-08 | Cardiff Oncology | Results Cardiff Oncology Announces New Data from Phase 1b/2 Trial in KRAS-mutated Metastatic Colorectal Cancer Showing Robust Objective Response Rate and Progression Free Survival cardiffoncology.com ↗
8 of 19 (42%) patients treated per protocol at the recommended Phase 2 dose (RP2D) of onvansertib 15 mg/m 2 who were evaluable for disease response as of the data cut-off achieved a partial response (PR). |
| 2021-04-12 | Cardiff Oncology | Results Cardiff Oncology Announces Onvansertib Phase 1b/2 Data that Continues to Demonstrate Robust Response to Treatment and Progression-Free Survival in KRAS-Mutated mCRC cardiffoncology.com ↗
Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, today announced data from its ongoing Phase 1b/2 trial that demonstrate the continued robust patient response to treatment with onvansertib and progression-free survival when combined with standard-of-care therapy in second line KRAS-mutated metastatic colorectal cancer (mCRC). |
| 2021-04-10 | Cardiff Oncology | Results Cardiff Oncology Presents Findings from its Expanded Access Program Highlighting the Clinical Benefit of Onvansertib in Heavily Pretreated Patients with Metastatic KRAS-Mutated mCRC cardiffoncology.com ↗
Median progression free survival (mPFS) is 5.6 months as of AACR cutoff date, which is significantly greater than historical controls of 2-3 months1 |
| 2021-04-10 | Cardiff Oncology | Results Cardiff Oncology in Collaboration with MIT Presents Gene Signature Analyses Data Identifying Androgen-Independent Mechanism for Onvansertib-Abiraterone Synergy in mCRPC cardiffoncology.com ↗
Onvansertib and the androgen receptor (AR) signaling inhibitor abiraterone synergize in an AR-independent manner in in-vitro and in-vivo metastatic castrate-resistant prostate cancer (mCRPC) models |
| 2021-03-10 | Cardiff Oncology | Results Cardiff Oncology Announces Upcoming Presentations at the AACR Annual Meeting 2021 cardiffoncology.com ↗
The findings show that of the 13 patients with a KRAS mutation detected in circulating tumor DNA (ctDNA) at baseline, 8 had a decrease of greater than 50% in KRAS mutant allelic frequency (MAF) following two treatment cycles of onvansertib (15 mg/m 2 , Days 1 to 5 of a 14-day cycle) in combination with FOLFIRI and bevacizumab (Day 1 of each cycle). |
| 2021-02-11 | Cardiff Oncology | Results Cardiff Oncology Presents Phase 2 mCRPC Trial Data Showing a Two-Fold Increase in Efficacy with an Optimized Onvansertib Dosing Schedule cardiffoncology.com ↗
75% (6/8) of evaluable patients in the optimized dosing cohort had stable disease upon radiographic scan at 12 weeks |
| 2021-01-26 | Cardiff Oncology | Regulatory Cardiff Oncology Receives "Study May Proceed" from FDA to Initiate Phase 2 Trial of Onvansertib in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) cardiffoncology.com ↗
today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of onvansertib in metastatic pancreatic ductal adenocarcinoma (PDAC). |
| 2021-01-15 | Cardiff Oncology | Results Cardiff Oncology Presents Data that Continues to Demonstrate the Clinical Benefit of Onvansertib in KRAS-Mutated mCRC and Initial Findings from its Expanded Access Program cardiffoncology.com ↗
Of the 12 Phase 1b patients evaluable for efficacy as of the ASCO-GI data cut-off date (November 1, 2020), 5 (42%) achieved a partial response (PR) and 8 (67%) have shown a durable response ranging from 6.1 to 13.7 months |
| 2020-12-06 | Cardiff Oncology | Results Cardiff Oncology Presents Data at ASH Demonstrating the Safety and Anti-Leukemic Activity of Onvansertib in Patients with Relapsed/Refractory AML cardiffoncology.com ↗
The presentation highlighted the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML. |
| 2020-10-20 | Cardiff Oncology | Results Cardiff Oncology Presents Positive Efficacy and Biomarker Data from mCRPC Trial Demonstrating Ability of Onvansertib to Overcome Zytiga® Resistance cardiffoncology.com ↗
Trial on track to meet prespecified criteria for success on its primary endpoint, with 31% (8/26) disease control rate in evaluable patients in cohorts A and B. |
| 2020-09-17 | Cardiff Oncology | Results Cardiff Oncology Presents Data at ESMO Confirming Efficacy of Onvansertib and Durability of Response in KRAS-Mutated Metastatic Colorectal Cancer (mCRC) cardiffoncology.com ↗
10 of 11 (91%) patients achieved disease control (SD - stable disease plus PR - partial response) with only 1 patient progressing in <6 months while on treatment |
| 2020-09-14 | Cardiff Oncology | Results Cardiff Oncology to Present Data Further Demonstrating the Safety and Efficacy of Onvansertib in KRAS-Mutated Metastatic Colorectal Cancer Patients cardiffoncology.com ↗
The abstract highlights preliminary clinical data from the Company's ongoing Phase 1b/2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated metastatic colorectal cancer. |
| 2020-06-15 | Cardiff Oncology | Results Cardiff Oncology Data Continues to Demonstrate Efficacy, Durability and Safety of Onvansertib in Patients with Difficult-to-Treat Relapsed/Refractory AML cardiffoncology.com ↗
Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m 2 ), indicating a large therapeutic window. |
| 2020-05-29 | Cardiff Oncology | Results Cardiff Oncology Data Continues to Demonstrate Efficacy of Onvansertib in Patients with KRAS-Mutated Metastatic Colorectal Cancer Presented at ASCO cardiffoncology.com ↗
To-date, 89% of evaluable patients in the onvansertib trial have achieved a clinical response and the response appears durable with patients having progression-free survival (PFS) of at least 6 months. |
| 2020-05-28 | Cardiff Oncology | Regulatory Cardiff Oncology Announces Fast Track Designation Granted by the FDA to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer cardiffoncology.com ↗
today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to onvansertib, its oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). |
| 2020-04-28 | Cardiff Oncology | Results Onvansertib Trial in KRAS-Mutated Colorectal Cancer Demonstrates Consistent Tumor Regression Across KRAS Mutation Subtypes and Durable Response cardiffoncology.com ↗ |
| 2020-02-13 | Cardiff Oncology | Results Trovagene Presents Phase 2 Data Demonstrating the Ability of Onvansertib to Overcome Zytiga®-Resistance and Provide Clinical Benefit for mCRPC Patients cardiffoncology.com ↗
In patients with AR alterations, 86% had decreases in PSA levels with the addition of onvansertib to daily Zytiga®. |
| 2020-01-27 | Cardiff Oncology | Results Onvasertib Demonstrates Effectiveness as Pan-KRAS Inhibitor with Confirmed Tumor Regression and Clinical Benefit Achieved in KRAS-Mutated mCRC Patients cardiffoncology.com ↗
All five patients evaluable for efficacy assessment have shown a significant reduction in their KRAS mutational burden as measured by a simple blood test, which was subsequently confirmed by tumor regression visible on radiographic scans. |
All press releases naming this drug 52 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Onvansertib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03829410 ↗ |
| Known as | NMS-1286937 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01014429 ↗ |
| Known as | NMS-P937 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738758 ↗ |
| Known as | Nms-p937 fumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738758 ↗ |
| Known as | Nms-p937 fumarate salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738758 ↗ |
| Known as | ONVANSERTIB FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738758 ↗ |
| Known as | PCM-075 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738758 ↗ |
| Known as | Pcm-075 fumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738758 ↗ |
| Known as | PMS-075H | ChEMBL registry synonym — accepted as the source's own label CHEMBL1738758 ↗ |
| Action | Inhibit | “polo-like-kinase 1 inhibitor” NCT01014429 ↗ |
| Modality | Small molecule | “Onvansertib is a small chemical molecule” NCT06398587 ↗ |
| Route | Oral | “Onvansertib orally” NCT03303339 ↗ |
| Target | PLK1 | “polo-like-kinase 1 inhibitor” NCT01014429 ↗ |