NKT3964 for Solid Tumors

Recruiting at 13 trial locations

Overseen By Sponsor Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NiKang Therapeutics, Inc.

Must not be taking: CDK2 inhibitors

Disqualifiers: Other malignancy, Cardiovascular event, CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NKT3964 for individuals with advanced or metastatic solid tumors. The main goals are to determine its safety, tolerability, and potential to shrink tumors. The trial begins with varying doses to identify the optimal amount, then assesses its effectiveness at that dose. It seeks participants with specific cancers, such as ovarian or certain breast cancers, who have previously tried unsuccessful treatments. Participants must have progressed on their last treatment and have tumors that are either resistant or not removable by surgery. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NKT3964 is likely to be safe for humans?

Research shows that NKT3964 is being tested for safety in people with advanced or spreading solid tumors. This early study evaluates how well the treatment is tolerated at different doses. As a Phase 1 study, it marks the initial testing stage in humans.

At this point, safety information is often limited, but the goal is to observe the body's response to the treatment and identify any side effects. If NKT3964 is well tolerated, it may proceed to further testing. However, because this treatment is still in early testing, detailed safety information from human trials is not yet available. Participants should consider these factors when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for solid tumors, like chemotherapy and radiation, work by killing rapidly dividing cells, which can also harm healthy cells. But NKT3964 works differently, targeting specific pathways unique to cancer cells, aiming to minimize damage to normal tissues. Researchers are excited about NKT3964 because it offers a potentially safer and more focused approach, with the added convenience of being an oral medication, making it easier for patients to take compared to traditional intravenous treatments.

What evidence suggests that NKT3964 might be an effective treatment for solid tumors?

Research shows that NKT3964 targets and breaks down a protein called CDK2, which is linked to tumor growth. In animal studies, NKT3964 reduced tumor size, with higher doses leading to more shrinkage. This trial tests NKT3964's ability to combat various advanced solid tumors, especially those unresponsive to standard treatments. Early results suggest it might help fight tumors, but more data is needed to confirm its effectiveness in humans. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced or metastatic solid tumors that have progressed after standard treatment. Eligible cancers include those with CCNE1 amplification, endometrial cancer, gastric cancer, small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and HR+/HER2- breast cancer resistant to CDK4/6 inhibitors.

Inclusion Criteria

My cancer has CCNE1 amplification.

My advanced cancer is not responding to current treatments.

My ovarian cancer has CCNE1 amplification.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3964 at increasing dosage levels to determine the MTD and/or preliminary RDEs.

28 days

Dose Expansion

Dose expansion will include 2 RDEs selected to determine the preliminary antitumor activity and the RP2D.

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• NKT3964

Trial Overview

The study tests NKT3964 in two phases: Dose Escalation to assess safety and dosage, and Expansion to evaluate its effectiveness at the best dose determined by response rate in shrinking or controlling tumor growth.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 1 Intervention

Dose expansion will include 2 RDEs selected to determine the preliminary antitumor activity and the RP2D.

Group II: Dose Escalation Experimental Treatment 1 Intervention

Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3964 at increasing dosage levels to determine the MTD and/or preliminary RDEs.

Who Is Running the Clinical Trial?

NiKang Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06586957

NCT06586957 | A Study With NKT3964 for Adults ...

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to ...

2.

rarecancernews.com

rarecancernews.com/news/phase-1-trial-nkt3964-gynecological-other-cancers-advances/

Study of NKT3964 in gynecological, other cancers advances

Also, in animal models of tumors marked by high cyclin E, NKT3964 was shown to break down CDK2 in a dose-dependent way, while reducing tumor ...

3.

withpower.com

withpower.com/trial/phase-1-carcinoma-8-2024-69ff9

NKT3964 for Solid Tumors

This trial is for adults with certain advanced or metastatic solid tumors that have progressed after standard treatment. Eligible cancers include those with ...

4.

synapse.patsnap.com

synapse.patsnap.com/article/nikang-unveils-nkt3964-a-potent-oral-cdk2-protac-degrader-for-cancer-at-eortc-nci-aacr-2024

NiKang Unveils NKT3964, a Potent Oral CDK2 PROTAC ...

This first-in-human study aims to establish the recommended dose for further expansion in adults with advanced or metastatic solid tumors. The ...

5.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT06586957

NKT3964 for Adults With Advanced/Metastatic Solid Tumors

The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDEs based on objective response rate (ORR) ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-with-nkt3964-for-adults-with-advanced-metastatic-solid-tumors

A Study With NKT3964 for Adults With Advanced/Metastatic ...

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor ...

7.

firstwordpharma.com

firstwordpharma.com/story/5906398

NiKang Therapeutics® Presents Discovery of NKT3964, a ...

This first-in-human study (NCT06586957) is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity ...

8.

biospace.com

biospace.com/press-releases/nikang-therapeutics-completes-dosing-of-the-first-cohort-in-a-phase-1-study-of-nkt3964-a-first-in-class-highly-potent-and-selective-orally-bioavailable-cdk2-degrader

NiKang Therapeutics® Completes Dosing of the First ...

NKT3964 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT06586957). About ...