NKT3964 for Solid Tumors

Recruiting at 7 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

90 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or 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) and determine the preliminary recommended Phase 2 dose (RP2D).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+