Today KORTUC Inc. announced that the first patient was enrolled in a global phase 1/2study for locally advanced cervical cancer with KRC-01.
Over half of cancer patients in the U.S. and Europe receive radiotherapy during the course of their treatment. However, the center and surrounding areas of tumor become hypoxic when the tumor grows to a certain size; this makes radiotherapy less effective in most solid tumors.
KRC-01 is expected to increase radiotherapy’s anti-tumor effect by (a) raising oxygen levels in the tumor thus increasing the effectiveness of radiation and (b) neutralizing antioxidant enzymes that also increase tumor radio resistance.
Cervical cancer is the fourth most common cancer among women globally, with an estimated 604,000 new cases/ 342,000 deaths in 2020, and about 90% of new cases and deaths occur in low- and middle-income countries 1) .
In addition, cervical cancer is known to a cancer for which intra-tumor hypoxia is associated with poor prognosis, and is considered to be a good candidate cancer for KRC-01 treatment.
This is a seamless phase 1/2 study. Phase 1 will evaluate the safety/tolerability of KRC-01in combination with chemoradiotherapy. Phase 2 is a randomized, controlled study to evaluate safety and efficacy compared to chemoradiotherapy alone in patients with locally advanced cervical cancer who are eligible for curative chemoradiotherapy.
Details of the study can be found at the following website:
Clinicaltrial.gov (NCT05570422)
https://clinicaltrials.gov/ct2/show/NCT05570422
1) Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49.