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NKT3964 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by NiKang Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

7. Other solid tumors with CCNE1 amplification

- Must have a pathologically confirmed unresectable advanced or metastatic solid tumor listed below with documented disease progression on last standard treatment. Patients must also be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to first test the safety and effectiveness of a new drug called NKT3964 in adults with advanced solid tumors. The initial phase will determine the safe dose of the drug, while the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of NKT3964 are not listed here, common ones may include nausea, fatigue, allergic reactions, blood count changes. Each person's experience can vary based on their health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has CCNE1 amplification.

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My advanced cancer is not responding to current treatments.

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My ovarian cancer has CCNE1 amplification.

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My breast cancer is HR+ and HER2-, and has worsened after CDK4/6 inhibitor treatment.

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My endometrial cancer has CCNE1 amplification.

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My cancer is in the stomach or esophagus and has a specific genetic change.

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My condition is small cell lung cancer.

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My breast cancer is triple-negative.

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My ovarian cancer returned within 6 months after platinum treatment and has a specific genetic change.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Dose Limiting Toxicity (DLT) events

Objective Response Rate (ORR)

Secondary study objectives

Accumulation ratio (AR)

Apparent clearance (CL/F)

Apparent volume of distribution (V/F)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

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

Group II: Dose EscalationExperimental Treatment1 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.

0 / 9Eligibility criteria met