Cardiff Oncology pipeline update: onvansertib trials, FDA meeting, and catalysts
Decision brief
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Cardiff Oncology is a clinical-stage biotechnology company advancing a PLK1 inhibitor across multiple oncology trials. This plan centers on onvansertib, recent FDA-related disclosure, and the company’s documented trial catalysts.
This Cardiff Oncology pipeline update focuses on onvansertib in first-line RAS-mutated metastatic colorectal cancer. After Phase 2 CRDF-004, Cardiff reported an April 2026 FDA End-of-Phase 2 meeting and plans for a Phase 3 trial of 30 mg onvansertib plus FOLFIRI/bevacizumab.
Contents10 sections
Key Takeaways
- Lead asset: onvansertib (oral PLK1 inhibitor) in RAS-mutated mCRC.
- CRDF-004 Phase 2 record: NCT06106308 (active, not recruiting).
- April 2026: successful FDA End-of-Phase 2 meeting; 30 mg + FOLFIRI/bev selected.
- ASCO 2026: company presented updated CRDF-004 results and confirmed Phase 3 design alignment.
What is driving the Cardiff Oncology pipeline now?
Cardiff Oncology is a clinical-stage company built around PLK1 inhibition. The Cardiff Oncology pipeline story today is almost entirely about onvansertib in first-line RAS-mutated metastatic colorectal cancer.
That setting still has high unmet need. Standard FOLFIRI or FOLFOX with bevacizumab remains the backbone Cardiff seeks to improve.
How did CRDF-004 shape the registrational path?
CRDF-004 is a randomized, controlled, dose-finding Phase 2 trial. It tests onvansertib with standard first-line regimens in RAS-mutated mCRC.
In January 2026 updates, Cardiff highlighted stronger confirmed objective response and progression-free survival for the 30 mg onvansertib plus FOLFIRI/bevacizumab arm versus standard-of-care arms. Those company-reported figures guided dose selection for Phase 3.
Trial registry: ClinicalTrials.gov NCT06106308.
What did the FDA End-of-Phase 2 meeting change?
In its May 14, 2026 Q1 update, Cardiff said it completed a successful End-of-Phase 2 meeting with FDA in April 2026. Management said the company aligned on key Phase 3 design elements.
The selected regimen is onvansertib 30 mg plus FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab alone in first-line RAS-mutated mCRC. Cardiff said it would share more Phase 3 detail and regulatory strategy in mid-2026.
Source: GlobeNewswire Q1 2026 business update.
ASCO 2026 data and Phase 3 design
At the 2026 ASCO Annual Meeting, Cardiff reported positive CRDF-004 results for the chosen 30 mg plus FOLFIRI/bevacizumab regimen. The company again said FDA End-of-Phase 2 alignment supports a randomized Phase 3 of that regimen versus standard-of-care FOLFIRI/bevacizumab.
- Dose selected: 30 mg onvansertib
- Chemo partner: FOLFIRI/bevacizumab
- Population: first-line RAS-mutated mCRC
- Next step: registrational Phase 3 initiation after final protocol details
ASCO-related company wire: GlobeNewswire Cardiff Oncology update (ASCO presentation noted in the Q1 release; detailed oral data followed at ASCO).
Trial snapshot for BD and CI teams
- NCT06106308 — Phase 2 CRDF-004; onvansertib + FOLFIRI/bev or FOLFOX/bev; status active, not recruiting
- Planned Phase 3 — 30 mg onvansertib + FOLFIRI/bev vs FOLFIRI/bev; design aligned with FDA per company
- Mechanism — oral PLK1 inhibitor
What remains unproven
Phase 2 gains do not prove Phase 3 success. FDA meeting alignment is not approval. Cardiff has not yet published a final Phase 3 sample size or primary endpoint package in the wires cited here.
ORR and hazard-ratio figures are company-reported from CRDF-004 cutoffs. Independent peer-reviewed confirmation should be checked when full manuscripts post.
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Frequently Asked Questions
What is the lead asset in the Cardiff Oncology pipeline?
Onvansertib, an oral PLK1 inhibitor, is the lead program. Cardiff is advancing it toward a Phase 3 registrational trial in first-line RAS-mutated metastatic colorectal cancer after Phase 2 CRDF-004 results.
What did the FDA End-of-Phase 2 meeting decide?
In April 2026, Cardiff said it completed a successful End-of-Phase 2 meeting and aligned with FDA on key Phase 3 design elements, including the 30 mg onvansertib dose with FOLFIRI/bevacizumab.
Which ClinicalTrials.gov record covers CRDF-004?
NCT06106308 is the Phase 2 study of onvansertib with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line RAS-mutated metastatic colorectal cancer; status is active, not recruiting.
Primary Sources
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