Carotuximab plus Erleada proved secure in a metastatic castration-resistant prostate most cancers section 2 trial: © inventory.adobe.com.
Carotuximab (ENV-105) was properly tolerated when mixed with the usual of care hormone remedy, Erleada (apalutamide), within the first 10 sufferers enrolled on a section 2 trial for metastatic castration-resistant prostate most cancers in; no severe negative effects had been reported.
These findings had been shared in a information launch from Kairos Pharma.
“The favorable security profile noticed on this section 2 examine is encouraging, because it validates our perception in ENV-105’s scientific potential and helps continued growth in a affected person inhabitants with restricted efficient remedy choices,” Dr. John Yu, CEO of Kairos Pharma, stated within the information launch.
The randomized section 2 trial is enrolling as much as 100 members and is at the moment open at Cedars-Sinai Medical Middle in Los Angeles, California; Metropolis of Hope in Duarte, California; and Huntsman Most cancers Middle in Salt Lake Metropolis, Utah. The examine is evaluating the protection, tolerability and early indicators of efficacy of ENV-105, a CD105-targeting remedy, in males whose prostate most cancers has progressed after commonplace hormone therapies. Interim outcomes are anticipated in September 2025, as per the information launch.
Individuals within the lively comparator group obtain standard-of-care Erleada at 240 milligrams (mg) taken orally as soon as every day in 28-day cycles. If their illness progresses, they could cross over to the mixture remedy group.
Individuals within the experimental group obtain the identical dose of Erleada together with intravenous carotuximab. Carotuximab is run at 3 mg per kilogram (mg/kg) on day one in every of cycle one, 7 mg/kg on day 4, and 10 mg/kg on days eight, 15 and 22. In cycle two, members obtain 15 mg/kg on days one and 15. Starting with cycle three, carotuximab is given at 15 mg/kg on day one in every of every 28-day cycle and continues on a once-every-four-weeks schedule.
To be eligible for this examine, sufferers should have a historical past of castration-resistant prostate most cancers with rising prostate-specific antigen (PSA) ranges whereas receiving a recent androgen receptor signaling inhibitor (ARSI), comparable to Zytiga (abiraterone), Xtandi (enzalutamide), or Nubeqa (darolutamide). Remedies like bicalutamide, nilutamide, and flutamide usually are not thought-about modern ARSIs. Sufferers should have acquired one or two prior AR-targeted therapies, not together with Erleada. Individuals should additionally both decline or be thought-about ineligible for taxane-based chemotherapy, within the opinion of their treating doctor. As well as, all members should agree to make use of an enough technique of contraception in the course of the examine and for no less than three months after their final dose of Erleada or carotuximab, as decided by the examine physician.
Sufferers can not participate within the examine if they’ve a type of prostate most cancers that doesn’t produce PSA, comparable to small cell prostate most cancers or most cancers that progresses on imaging with out a PSA improve. Earlier remedy with Erleada or any CD105-targeting antibody, together with carotuximab, can also be not allowed. Different exclusion standards embrace having one other lively most cancers that requires remedy, any situation that poses a excessive danger of bleeding, or a identified analysis of Osler-Weber-Rendu syndrome.
With roughly a million males identified with prostate most cancers every year within the U.S., and thousands and thousands extra worldwide, resistance to hormone remedy represents a rising problem for sufferers — notably in an getting old inhabitants, in response to the information launch. Castration-resistant prostate most cancers refers to illness that progresses regardless of hormone-blocking remedy, and choices stay restricted as soon as these therapies cease working.
Kairos Pharma is creating ENV-105 as a possible various and plans to fulfill with regulatory companies to debate a attainable section 3 trial based mostly on rising knowledge.
Reference
“Kairos Pharma Pronounces Optimistic Security Outcomes from Part 2 Trial of ENV-105 in Superior Prostate Most cancers,” July 15, 2025, Kairos Pharma.
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