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
NiKang Therapeutics, Inc.
Summary
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 RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).
Description
Inclusion Criteria: \- Must have a pathologically confirmed, advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. For Part 1 only: Patients must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. Part 1 Dose Escalation and Food Effect Sub-study: 1. Ovarian cancer 2. Endometrial cancer (only 'endometrioid' subtype requires CCNE1 amplification) 3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification 4. Small cell lu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. Dose Escalation: 1. Ovarian cancer 2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification) 3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification 4. Small cell lung cancer (SCLC) 5. Triple-negative b…
Interventions
- DrugNKT3964
Oral CDK2 Degrader
Locations (19)
- University of Arkansas Medical SchoolLittle Rock, Arkansas
- University of California - Los AngelesLos Angeles, California
- UCSFSan Francisco, California
- SCRI at HealthOneDenver, Colorado
- Florida Cancer Specialists & Research InstituteLake Mary, Florida
- AdventHealth Cancer InstituteOrlando, Florida