Cardiff Oncology Inc (Cardiff) concentrates on creating new treatments by inhibiting Polo-like kinase 1 (PLK1), an established oncology target. The company seeks to meet major unmet needs across multiple cancers by leveraging tumor weaknesses with its lead candidate, onvansertib, an oral, highly selective PLK1 inhibitor. Onvansertib shows strong selectivity and potency against PLK1, with an IC50 of 2 nM, and little activity on other kinases, supporting a positive safety profile in early trials. It has a 24-hour half-life, enabling adaptable dosing regimens. Preclinical evidence suggests onvansertib produces synergistic activity when paired with numerous standard cancer therapies, including cytotoxic drugs and targeted agents. Cardiff is progressing five onvansertib clinical studies. The lead program, CRDF-004, is a Phase 2 randomized trial evaluating onvansertib plus standard-of-care in first-line RAS-mutated metastatic colorectal cancer (mCRC). In addition, investigator-initiated trials are underway or planned in metastatic pancreatic ductal adenocarcinoma, relapsed small cell lung cancer, and unresectable locally advanced or metastatic triple-negative breast cancer. This study tests two onvansertib dose levels with either FOLFIRI or FOLFOX plus bevacizumab, seeking to measure safety and efficacy. Cardiff is running the TROV-054 study, a Phase 1b/2 trial examining onvansertib with FOLFIRI and bevacizumab in second-line KRAS-mutated mCRC. It emphasizes identifying dose-limiting toxicities and setting a recommended Phase 2 dose, while evaluating safety and early efficacy signals. The company’s focus on pancreatic cancer includes a Phase 2 first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trial testing onvansertib with Gemzar and Abraxane. Another key study, CRDF-001, evaluates onvansertib combined with nanoliposomal irinotecan for second-line mPDAC across several sites. Cardiff is also assessing onvansertib in small-cell lung cancer (SCLC) and triple-negative breast cancer (TNBC). A Phase 2 relapsed SCLC trial targets objective response rates, while a separate investigator-initiated TNBC trial studies onvansertib with paclitaxel.

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The company’s R&D is focused on the development of its lead drug candidate, onvansertib, which is in the early stages of clinical development. The company is conducting multiple clinical trials across various cancer indications, including RAS-mutated metastatic colorectal cancer (mCRC), pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC). The company is exploring the efficacy of onvansertib in combination with standard-of-care cancer agents and is utilizing biomarker analyses to optimize drug development and patient care. The company has an in-house research and development laboratory in San Diego, California. This unit is responsible for optimizing drug development and patient care, conducting correlative biomarker analyses, and supporting the clinical development of onvansertib. It has 51 issued patents and 65 pending patent applications in the U.S. and abroad. In FY2025, the company invested US$35.3 million in its R&D activities, which declined 4.1% YoY.