NKT5097 for Advanced Solid Tumors

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Recruiting Phase 1 Interventional Study
HR+ Breast Cancer Triple Negative Breast Cancer (TNBC) CCNE1 Amplified Advanced Solid Tumors HR+ HER2- Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
361 (estimated)
Sponsor
NiKang Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with advanced solid tumors, especially certain types of breast cancer that are hard to treat. Participants will test a new medication called NKT5097 to see how safe it is and what side effects it may cause.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years old or older.
  • I have an advanced solid tumor that cannot be easily removed.
  • I have been diagnosed with certain hard-to-treat breast cancers.
  • I have not responded to or cannot tolerate existing cancer treatments.
  • I can provide a sample of my tumor tissue.
  • I can swallow pills.
  • I have a good level of overall health.

You may not be able to join if

  • I have a solid tumor that can still be treated with curative methods.
  • I had another type of cancer in the past, except for certain skin cancers or other cancers that were fully treated and are now in remission.
  • I have not fully recovered from previous cancer treatments.
  • I had a serious heart problem in the last 6 months.
  • I have active cancer spreading to my brain.
  • I have a serious lung condition that needs treatment.
  • I had major surgery within the last 30 days.
  • I have significant liver disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET * What medical issues/sym…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Able to provide written informed consent * Advanced unresectable or metastatic solid tumor (Part 1, 2 \& 3 only) * Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 \& 5 only) * Refractory to or unable to tolerate existing therapies (Part 1, 2 \& 4 only) * Me…
Contacts

Sponsor Contact

302-596-8654

clinicaltrials@nikangtx.com

CONTACT