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News|Articles|February 2, 2026 (Updated: February 19, 2026)

PRV211 Generates Promising Safety Outcomes in Invasive Oral Cavity Cancer

Author(s)Kyle Doherty
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Key Takeaways

  • CLN-004 is an open-label, multiarm study assessing PRV111 for carcinoma in situ (arm 1) and intraoperative PRV211 for T1–T3, Nx, M0 resectable oral cancer (arm 2).
  • Arm 2 incorporates a phase 1b dose-confirmation followed by a single-arm phase 2 expansion, with eligibility requiring accessible tumors, ECOG ≤2, and surgery within 8 weeks.
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PRV211 was safe with no SAEs, systemic toxicities, or DLTs for the treatment of patients with invasive oral cavity cancer.

PRV211 (intraoperative cisplatin system) demonstrated encouraging safety outcomes in patients with invasive oral cavity cancer, according to data from arm 2 of the phase 2/3 CLN-004 trial (NCT05893888). Enrollment for arm 2 was also completed.1

Findings from the phase 1/2 safety cohort of arm 2 (n = 8) revealed that no treatment-related serious adverse effects, systemic toxicities, or dose-limiting toxicities (DLTs) occurred. One instance of a mild burning sensation during healing was reported. Additionally, there were no reports of delayed wound healing or healing complications. Overall, PRV211 was well tolerated per clinical laboratory assessments and postsurgical examinations conducted at the 1-month follow-up visit.

The pharmacokinetic profile assessments of PRV211 indicated negligible systemic platinum absorption and validated targeted delivery with minimal off-target effects. Patients will continue to be monitored for efficacy outcomes, which will be assessed by the rate of locoregional recurrence at 12 months post surgery.

"This study represents an important step forward in our approach to cancer surgery," Manijeh Goldberg, PhD, founder and CEO of Privo Technologies, stated in a news release.1 "PRV211 is customized medicine that enables surgeons to deliver targeted treatment precisely where recurrence risk is highest."

PRV211 is a sterile intraoperative patch intended for integration into standard surgical workflows; it builds on the nanoengineered polymer platform of PRV111.1,2 The patch is administered immediately following tumor resection and is designed to deliver localized chemotherapy to the surgical bed while minimizing systemic exposure.1

PRV211 Arm of CLN-004 Meets Primary End Point: Key Takeaways

  • PRV211 is a sterile intraoperative patch intended for integration into standard surgical workflows which builds on the nanoengineered polymer platform of PRV111 (cisplatin transmucosal system).
  • Patients with invasive oral cavity cancer in arm 2 of the phase 1/2 safety cohort of CLN-004 experienced no SAEs, systemic toxicities, or DLTs; these findings met the primary safety end point of the study.
  • Privo Technologies also announced that enrollment for arm 2 of CLN-004 has been completed.

What are the key design characteristics of CLN-004?

CLN-004 is an open-label study that examined PRV111 and PRV211 for the treatment of patients with oral squamous cell carcinoma.2 Arm 1 evaluated PRV111 in patients with carcinoma in situ and included a phase 2/3 run-in. Arm 2 examined the safety of PRV211 in the intraoperative setting and included a phase 1b dose confirmation portion in patients with T1 to T3, Nx, M0 oral cancer, followed by an expansion phase 2 single-arm portion. To be eligible for both arms, patients had to be at least 18 years old, have tumors that are accessible, with no evidence of infection or active bleeding, have disease amenable to surgical resection within 8 weeks of screening, have an ECOG performance status of 2 or less, and have a life expectancy of at least 3 months.

In arm 2, patients had PRV211 placed into the resected tumor bed. The PRV211 system included a liquid permeation enhancer and a cisplatin patch. The permeation was brushed onto the resected tumor bed, and the patch was applied directly over the same area after 5 minutes; up to 2 layers of the PRV211 system were applied to the tumor bed post resection. PRV211 treatment duration was approximately 10 to 20 minutes at a proposed starting dose of 0.5 mg/cm2 of cisplatin.

The primary end point in arm 2 was safety, defined as the incidence of DLTs at 1-month post surgery and through study completion at approximately 12 months to 14 months. Secondary end points in both arms included event-free survival and pharmacokinetics via platinum levels in blood.

What other data have been reported from CLN-004?

Privo Technologies, the developer of PRV211, announced that the primary efficacy end point was met in arm 1 and that arm 3 was successfully initiated.1 A future expansion study is planned to further evaluate the efficacy of PRV211 based on locoregional recurrence outcomes, according to the news release.

References

  1. Privo Technologies successfully completes phase 1/2 study of PRV211 intraoperative chemotherapy for head and neck cancer patients. News release. Privo Technologies. January 23, 2026. Accessed February 19, 2026. https://www.prnewswire.com/news-releases/privo-technologies-announces-milestone-in-prv211-arm-of-cln-004-clinical-trial-primary-endpoint-met-no-serious-adverse-events-reported-302668552.html
  2. Safety and efficacy study of PRV111 and PRV211 in subjects with oral squamous cell carcinoma. ClinicalTrials.gov. Updated June 15, 2025. Accessed February 2, 2026. https://clinicaltrials.gov/study/NCT05893888

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