RecruitingSolid TumorAdvanced Solid TumorSolid Tumor, Adult

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

Eligible age

18+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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).

Sponsor: NiKang Therapeutics, Inc.

You may qualify if…

✓ \- 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 breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)
✓ 6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy \[ET\])

You may not qualify if…

✕ 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)
✕ Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment
✕ Known active CNS metastases and/or carcinomatous meningitis
✕ Active interstitial lung disease currently requiring treatment
✕ History of uveitis, retinopathy or other clinically significant retinal disease