Cardiff Oncology Announces Completion of Enrollment in Phase 2 CRDF-004 Trial Evaluating Onvansertib for the Treatment of First-line RAS-mutated Metastatic Colorectal Cancer

Rhea-AI Summary

Cardiff Oncology (CRDF) has completed patient enrollment in its Phase 2 CRDF-004 trial, evaluating onvansertib combined with standard of care for first-line RAS-mutated metastatic colorectal cancer (mCRC) treatment. The trial, conducted across 41 U.S. clinical sites, involves patients with documented KRAS or NRAS mutations and unresectable disease.

The study design includes three arms where patients receive either 20mg onvansertib plus standard of care (FOLFIRI/FOLFOX with bevacizumab), 30mg onvansertib plus standard of care, or standard of care alone. The trial's primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival, duration of response, and safety.

Initial results were released in December 2024, with additional clinical data expected in the first half of 2025.

Positive

• Successful completion of patient enrollment in Phase 2 trial
• Trial targets first-line treatment, potentially expanding market opportunity
• Company progressing towards FDA regulatory discussions

Negative

• Additional clinical data not available until 1H 2025
• Faces competition in well-established standard of care treatment landscape

Insights

Biotechnology R&D Expert

Cardiff Oncology's completion of enrollment in their Phase 2 CRDF-004 trial represents a critical operational milestone in their clinical development program. This trial targeting RAS-mutated metastatic colorectal cancer addresses a significant unmet need, as patients with these mutations have historically had therapeutic options.

The trial design is particularly robust with 41 clinical sites across the U.S. and a three-arm randomization structure (20mg onvansertib+SoC, 30mg onvansertib+SoC, or SoC alone). The primary endpoint of objective response rate (ORR) with secondary endpoints including progression-free survival provides a comprehensive efficacy assessment framework.

What's most significant clinically is that this is positioning onvansertib as a first-line treatment, not just in refractory settings. PLK1 inhibition represents a novel mechanistic approach in RAS-mutated tumors, potentially offering a new treatment paradigm in a space that, as the CEO notes, "have not seen meaningful treatment advancements for decades."

The mention of advancing toward FDA discussions suggests Cardiff believes their emerging data profile could support a regulatory pathway. However, the true value-determining moment remains the upcoming data readout in 1H 2025. While enrollment completion is necessary for trial progression, it primarily confirms the company is executing according to its clinical development timeline rather than providing new efficacy insights beyond what was potentially shared in December 2024.

Biotech Investment Analyst

From an investment perspective, Cardiff Oncology's enrollment completion primarily represents a de-risking of execution uncertainty rather than a fundamental value inflection point. For clinical-stage biotechs with $185.6M market capitalization, adherence to development timelines is crucial for cash runway management and investor confidence.

This milestone maintains the company's previously communicated data readout timeline for 1H 2025, providing a clear catalyst window for investors. The enrollment of the full patient cohort across the three treatment arms enables more reliable statistical powering for the trial's primary and secondary endpoints.

The company's strategic focus on first-line RAS-mutated mCRC positions onvansertib for potentially larger market opportunity compared to later-line treatments. However, investors should note that the true value driver will be the quality of efficacy data relative to standard-of-care in the upcoming readout.

While this announcement demonstrates operational competence, it doesn't fundamentally alter the risk/reward profile that was established after the initial results disclosed in December 2024. The company's mention of advancing toward FDA discussions indicates confidence but requires substantiation through robust clinical data.

This milestone maintains Cardiff's position in the clinical development race but represents an expected progression point rather than surprising positive or negative news that would warrant significant revaluation of the company's prospects.

- Initial results from randomized Phase 2 CRDF-004 trial in RAS-mut mCRC were released in December 2024 -

- Additional clinical data from CRDF-004 trial expected in 1H 2025 -

SAN DIEGO, April 15, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced completion of patient enrollment in the ongoing Phase 2 CRDF-004 trial evaluating onvansertib in combination with standard of care (SoC) for the treatment of first-line RAS-mutated metastatic colorectal cancer (mCRC).

“The successful completion of enrollment in our first-line trial for patients with RAS mutant mCRC represents an important milestone in our mission to develop new treatments for a population who have not seen meaningful treatment advancements for decades. We are deeply grateful for our patients, care-givers and clinical investigators, whose commitment to the trial has been integral in this achievement,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “As we move forward, we are eager to continue accruing additional clinical data and advancing towards regulatory discussions with FDA with the goal of bringing this transformative therapy to patients.”

The Phase 2 CRDF-004 trial has reached our targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. Patients in the trial have a documented KRAS or NRAS mutation with unresectable disease. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients are randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety.

The company anticipates reporting additional clinical data from the CRDF-004 trial in the first half of 2025.

About Cardiff Oncology, Inc.

Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com

Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com

Media Contact:
Michael Laurer
Taft Communications
732-233-4881
michael.lauer@rfbinder.com

FAQ

What are the key endpoints in Cardiff Oncology's CRDF-004 Phase 2 trial for colorectal cancer?

The primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response (DOR), and safety.

When will Cardiff Oncology (CRDF) release additional data from the Phase 2 CRDF-004 trial?

Additional clinical data from the CRDF-004 trial is expected in the first half of 2025.

How many clinical sites are involved in Cardiff Oncology's CRDF-004 Phase 2 trial?

The trial is being conducted across 41 clinical sites in the United States.

What are the treatment arms in Cardiff Oncology's Phase 2 CRDF-004 trial?

The trial has three arms: 20mg onvansertib plus standard of care, 30mg onvansertib plus standard of care, or standard of care alone.