KTX-2001 for Prostate Cancer

(STRIKE-001 Trial)

Recruiting at 1 trial location

Overseen By Miriam Barnett, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: K36 Therapeutics, Inc.

Must be taking: ARPI

Must not be taking: Strong CYP3A inducers

Disqualifiers: Brain metastases, Infections, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, KTX-2001, both alone and with darolutamide, to determine their safety and effectiveness in treating a type of prostate cancer that has spread and does not respond to low testosterone levels. Researchers seek to understand how these drugs work in the body and whether they can help manage this advanced cancer. Men with prostate cancer that has spread to bones or other areas after previous treatments might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires you to stop using certain medications, especially those that strongly affect liver enzymes (CYP3A inducers or inhibitors) and some herbal products. You should also avoid starting new hormonal treatments for prostate cancer during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is testing KTX-2001 to determine its safety for people with prostate cancer. This marks its first trial in humans, so detailed safety information is not yet available. The trial is in its early stages, focusing primarily on safety and determining the correct dose.

More information exists regarding the combination of KTX-2001 with darolutamide. Darolutamide, already used for prostate cancer, is generally well-tolerated. Previous studies have found that patients taking darolutamide experienced a better quality of life and fewer cancer symptoms.

In summary, while researchers are still assessing the safety of KTX-2001, darolutamide has an established safety record. Participants in the trial will help researchers evaluate the safety and effectiveness of KTX-2001 both alone and in combination with darolutamide. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

KTX-2001 is unique because it targets prostate cancer differently from typical hormonal therapies. While most treatments focus on blocking or reducing androgens, KTX-2001 works by inhibiting a specific pathway involved in cancer cell growth. Additionally, in one treatment arm, KTX-2001 is combined with Darolutamide, an established androgen receptor inhibitor, potentially enhancing its effectiveness by attacking the cancer from multiple angles. Researchers are excited about this innovative approach because it offers a new way to tackle prostate cancer, which might lead to better outcomes for patients.

What evidence suggests that KTX-2001 might be an effective treatment for prostate cancer?

Research has shown that KTX-2001 targets a specific protein that aids cancer cell survival, potentially stopping the growth and spread of advanced prostate cancer cells. Although limited data from human studies exist, early research suggests this could offer a new treatment approach for challenging prostate cancer cases. In this trial, some participants will receive KTX-2001 alone, while others will receive it in combination with darolutamide. Darolutamide has already improved quality of life and slowed cancer progression in prostate cancer patients. These early findings suggest that the combination could effectively manage this aggressive cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Jason Redman, MD

Principal Investigator

K36 Therapeutics

Are You a Good Fit for This Trial?

This trial is for men with metastatic castration-resistant prostate cancer. Participants should meet specific health criteria not detailed here. Those who have other medical conditions or treatments that could interfere with the study may be excluded.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am a male with advanced prostate cancer that is resistant to hormonal therapy.

My blood counts are within the required range and I haven't had a transfusion in the last 2 weeks.

Exclusion Criteria

I have been on stable hormone therapy for prostate cancer for over 6 months.

I haven't used any herbal products or alternative therapies that might affect PSA levels or act against prostate cancer in the last 4 weeks.

I do not have an active infection like HIV, HBV, or HCV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Part A

Participants receive KTX-2001 orally to assess safety, pharmacokinetics, and pharmacodynamics

4-8 weeks

Dose Escalation Combination Part B

Participants receive KTX-2001 in combination with darolutamide to assess safety and establish recommended Phase 2 dose

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KTX-2001

Trial Overview The trial is testing KTX-2001 alone and in combination with Darolutamide to see if they're safe, how well they work against prostate cancer, and how the body responds to them. It's a first-in-human study which means it's the first time these drugs are being tested in people.

How Is the Trial Designed?

Group I: Part B: Dose Escalation Combination Experimental Treatment 1 Intervention

KTX-2001 orally Darolutamide (NUBEQA®) orally as 600 mg BID, total daily dose at 1200 mg

Group II: Dose Escalation Part A Experimental Treatment 1 Intervention

KTX-2001 orally

Who Is Running the Clinical Trial?

K36 Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

130+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07103018

NCT07103018 | A Clinical Study of KTX-2001 in Subjects ... The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic ...

2. k36tx.com k36tx.com/the-ktx-2001-program

KTX-2001 Prostate Cancer Emerging data highlight that elevated H3K36me2 enables transcriptional plasticity, allowing cancer cells to bypass apoptosis and resist standard-of-care ...

3. urologytimes.com urologytimes.com/view/fda-greenlights-phase-1-trial-of-nsd2-inhibitor-in-mcrpc

FDA greenlights phase 1 trial of NSD2 inhibitor in mCRPC The phase 1 STRIKE-001 trial will evaluate KTX-2001 as both a monotherapy and in combination with darolutamide.

4. withpower.com withpower.com/trial/phase-1-urogenital-neoplasms-8-2025-358b2

KTX-2001 for Prostate Cancer · Info for Participants The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic ...

5. prnewswire.com prnewswire.com/news-releases/k36-therapeutics-receives-fda-clearance-of-investigational-new-drug-ind-application-for-ktx-2001-in-metastatic-castration-resistant-prostate-cancer-mcrpc-and-announces-clinical-trial-collaboration-with-bayer-for-supply-of-daro-302523702.html

K36 Therapeutics Receives FDA Clearance of ... This Phase 1 program will evaluate KTX-2001 both as a monotherapy and in combination with Bayer's androgen receptor inhibitor, darolutamide, for ...