Kairos Pharma Modified Prostate Cancer Drug Trial Protocol

The company expanded its phase 2 study for ENV-105 to reach more patients and accelerate trial enrollment timelines.

Updated on Oct. 6, 2026 in Cancer

Isometric editorial illustration of a glass beaker and pipette on a white surface, representing clinical research processes. — Kairos Pharma has updated its phase 2 clinical trial protocol for the prostate cancer treatment ENV-105 to accelerate patient enrollment targets. AI Illustration. Upload story photo >

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Kairos Pharma has updated the phase 2 protocol for its prostate cancer treatment, ENV-105, to include patients with rising PSA levels. The trial aims to enroll 116 patients to evaluate the drug alongside existing therapies.

Why it matters

Modifying the study design helps the developer reach a broader patient population while seeking to improve clinical enrollment speed. The adjustments come as the company manages tight financial resources during its ongoing research phase.

A prior safety lead-in of 10 patients showed a 17.7-month median progression-free survival for the ENV-105 combination versus two months for monotherapy. The full trial is designed to enroll 116 participants.

The players

Kairos Pharma

This is a pharmaceutical company currently developing novel therapies for oncology patients.

Cedars-Sinai Medical Center

This is a non-profit academic healthcare organization based in Los Angeles that serves as a primary site for clinical research.

The details

The updated study targets the CD105 receptor in castration-resistant prostate cancer patients who have seen PSA levels rise after prior androgen signaling inhibitor treatment. Investigators will randomize participants into arms receiving either Xtandi and ENV-105 or monotherapy.

A physician at Cedars-Sinai Medical Center began the trial in 2023.
Researchers shared results from the 10-patient safety lead-in in September 2025.
Kairos reported $2.6 million in cash reserves as of June 2026.
The company aims to complete the phase 2 trial by the fourth quarter of 2027.

The Big Picture

This modification follows a pattern set by the broader CD105 receptor targeting research program. It extends clinical exploration by incorporating patients who have demonstrated resistance to standard androgen signaling inhibitors.

The expansion of this trial may provide new treatment options for patients whose prostate cancer has progressed despite standard therapies. Participants in the study will be randomized to receive ENV-105 in combination with Xtandi.

The takeaway

Prostate cancer patients should consult with their oncologists to determine if they qualify for enrollment in emerging clinical trials. Understanding the progression-free survival metrics of new drug combinations is essential for patients weighing different treatment paths.