J Gynecol Oncol.
2024 Jul;35(4):e52. 10.3802/jgo.2024.35.e52.
A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2
- Affiliations
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- 1Department of Obstetrics and Gynecology, Korea University Guro Hospital, Seoul, Korea
- 2Comprehensive Gynecologic Cancer Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea
- 3Department of Obstetrics and Gynecology, Institute of Women’s Life Medical Science, Yonsei University College of Medicine, Seoul, Korea
- 4Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea
- 5Department of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu, Korea
- 6Department of Obstetrics and Gynecology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 7Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, Korea
- 8Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan, Seoul, Korea
- KMID: 2564922
- DOI: http://doi.org/10.3802/jgo.2024.35.e52
Abstract
Objective
This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2).
Methods
We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women. In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load.
Results
A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed.
Conclusion
The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.
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