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.
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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
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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

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