Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing NKT3964 for Solid Tumor

The goal of the this drug alone Dose Escalation phase (Part 1) of the study is to measure 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 this drug alone Expansion phase of the study (Part 2) is to measure the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

Official registry: https://clinicaltrials.gov/study/NCT06586957 · NiKang Therapeutics, Inc. · enrollment listed as 238

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are NKT3964, Paclitaxel, or Doxorubicin. The registry lists allocation as randomized. The goal of the this drug alone Dose Escalation phase (Part 1) of the study is to measure 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.

They plan to enroll about 238 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors

Interventions: NKT3964, Paclitaxel, Doxorubicin

Primary outcome (registry wording): Number of Participants with Dose Limiting Toxicity (DLT) events

Who it is for (from inclusion criteria)

  • Ages 19 Years to any
  • Part 1 this drug alone Dose Escalation:
  • Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)
  • Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification
  • Small cell lung cancer (SCLC)
  • Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)
  • HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy \[ET\])
  • Other solid tumors with CCNE1 amplification

Public study contact (from the registry)

Sponsor Contact

(302) 596-8654

clinicaltrials@nikangtx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

21 listed

+ 2 sites outside the US on the same record

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NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT06586957 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06586957?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06586957?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary