A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

Summary

The goal of the Monotherapy Dose Escalation phase (Part 1) 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 Monotherapy Expansion phase of the study (Part 2) 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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Solid Tumor
• Advanced Solid Tumor
• Solid Tumor, Adult
• Metastatic Tumor
• Ovarian Cancer
• Ovarian Neoplasms
• Ovarian Carcinoma
• Metastatic Ovarian Carcinoma
• Endometrial Neoplasms
• Endometrial Diseases
• Metastatic Endometrial Cancer
• Triple Negative Breast Cancer
• Metastatic Endometrial Carcinoma
• Advanced Endometrial Carcinoma
• Advanced Ovarian Carcinoma
• Gastric Cancer
• Advanced Gastric Carcinoma
• Metastatic Gastric Cancer
• Metastatic Gastric Carcinoma
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Triple Negative Breast Neoplasms
• Platinum-resistant Ovarian Cancer
• Platinum-refractory Ovarian Carcinoma
• CCNE1 Amplification
• Hormone Receptor Negative Breast Carcinoma
• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
• Progesterone-receptor-positive Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

19 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

NiKang Therapeutics, Inc.

Last updated on ClinicalTrials.gov

October 6, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites