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.
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