SAN DIEGO, Calif., May 21, 2026
Cardiff Oncology, Inc. announced that updated data from its ongoing Phase 2 CRDF-004 clinical trial evaluating onvansertib in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC) will be presented during a rapid oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2026. The company also confirmed it will host an investor webcast on June 3, 2026, to discuss the updated findings and future development plans for the therapy. The announcement highlights growing momentum around onvansertib, Cardiff Oncology’s lead investigational therapy targeting Polo-like kinase 1 (PLK1), a validated cancer target associated with tumor progression and treatment resistance in several aggressive cancers.
Updated CRDF-004 Trial Data to Highlight Progress in RAS-Mutated mCRC
The CRDF-004 study is a randomized, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care chemotherapy regimens, including FOLFIRI/bevacizumab and FOLFOX/bevacizumab, in patients with first-line RAS-mutated metastatic colorectal cancer. The updated results scheduled for presentation at ASCO 2026 build upon previously released January 2026 findings that demonstrated encouraging improvements in treatment response and progression-free survival.
According to Cardiff Oncology, earlier data from the trial showed that combining onvansertib with FOLFIRI and bevacizumab generated dose-dependent improvements in overall response rates and progression-free survival compared with standard-of-care treatment alone. Based on these positive outcomes, the company selected the 30 mg dose of onvansertib for advancement into a future registrational trial targeting first-line RAS-mutated mCRC patients, a patient population with substantial unmet clinical need and limited targeted treatment options.
The company stated that the ASCO presentation will provide additional efficacy, safety, and clinical outcome data from the CRDF-004 study, potentially strengthening the case for onvansertib as a novel targeted therapy in colorectal cancer. RAS mutations are among the most common genetic alterations in colorectal cancer and are frequently associated with poorer treatment outcomes and resistance to currently available therapies.
Onvansertib Advances as a Targeted PLK1 Inhibitor in Multiple Cancer Types
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Onvansertib is an investigational, highly selective oral PLK1 inhibitor designed to target tumor cell division and replication pathways. PLK1 plays a critical role in cancer cell proliferation, making it an attractive therapeutic target in several difficult-to-treat cancers. Cardiff Oncology believes the therapy’s mechanism could help overcome resistance to conventional chemotherapy and improve patient outcomes when combined with established treatment regimens.
Beyond colorectal cancer, onvansertib is also being investigated through multiple investigator-initiated studies in several additional tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML). The company noted that early-stage studies have demonstrated promising single-agent activity in select hard-to-treat cancers, supporting broader development opportunities for the therapy.
Cardiff Oncology continues to position PLK1 inhibition as a potentially practice-changing strategy in oncology, particularly in cancers driven by aggressive molecular pathways and treatment resistance mechanisms. The company’s leadership stated that the updated ASCO data could represent an important milestone in advancing onvansertib toward late-stage clinical development and eventual regulatory discussions.
Investor Webcast Scheduled Following ASCO Presentation
Cardiff Oncology confirmed it will host an investor webcast on June 3, 2026, at 8:30 a.m. ET to review the updated Phase 2 findings presented at ASCO 2026. Members of the company’s management team are expected to discuss the significance of the data, ongoing clinical development plans, and the future regulatory pathway for onvansertib in metastatic colorectal cancer.
With colorectal cancer remaining one of the leading causes of cancer-related deaths globally, industry observers will closely watch the upcoming ASCO presentation for evidence that PLK1 inhibition could emerge as a meaningful new treatment approach for patients with RAS-mutated metastatic colorectal cancer.
Source: Cardiff Oncology press release
