Health Trials

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

ConditionsSolid TumorAdvanced Solid TumorSolid Tumor, AdultMetastatic TumorOvarian CancerOvarian NeoplasmsOvarian CarcinomaMetastatic Ovarian CarcinomaEndometrial NeoplasmsEndometrial DiseasesMetastatic Endometrial CancerTriple Negative Breast CancerMetastatic Endometrial CarcinomaAdvanced Endometrial CarcinomaAdvanced Ovarian CarcinomaGastric CancerAdvanced Gastric CarcinomaMetastatic Gastric CancerMetastatic Gastric CarcinomaSmall Cell Lung CancerSmall Cell Lung CarcinomaTriple Negative Breast NeoplasmsPlatinum-resistant Ovarian CancerPlatinum-refractory Ovarian CarcinomaCCNE1 AmplificationHormone Receptor Negative Breast CarcinomaHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastProgesterone-receptor-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNiKang Therapeutics, Inc.

About this trial

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).

Eligibility criteria

Qualifiers

Ovarian cancer

Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)

Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification

Small cell lung cancer (SCLC)

Disqualifiers

Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.

History of another malignancy with exceptions

History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.

Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)

Trial design

Treatments tested in this trial

  • NKT3964

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NiKang Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov