A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-23

Study Completion Date

2025-04-16

Brief Summary

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The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D).

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Detailed Description

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This is a Phase 1/1b, first-in-human, open-label, multicenter study of NKT3447 in adults with advanced/ metastatic solid tumors. The study consists of 2 parts, a Dose Escalation phase and a Dose Expansion phase. Eligible patients must have confirmed advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the investigator.

Dose Escalation:

1. Ovarian cancer
2. Endometrial cancer
3. Gastric cancer or gastroesophageal junction cancer
4. Small cell lung cancer
5. Triple-negative breast cancer (human epidermal growth factor receptor 2, estrogen receptor, progesterone receptor negative)
6. Estrogen receptor/progesterone-receptor positive (ER+/PR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy)
7. Other solid tumors with CCNE1 amplification as determined by next generation sequencing by local liquid or tissue biopsy.

Dose Expansion:

a. Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with cyclin E amplification as determined by fluorescence in situ hybridization, quantitative polymerase chain reaction, or next-generation sequencing by local liquid or tissue biopsy.

The Dose Escalation phase will evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors.

The Dose Expansion phase will evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with CCNE1 amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended RP2D.

Conditions

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Solid Tumor Solid Tumor, Adult Advanced Solid Tumor Metastatic Tumor Ovarian Cancer Ovarian Neoplasms Ovarian Carcinoma Metastatic Ovarian Carcinoma Endometrial Cancer Endometrial Neoplasms Endometrial Diseases Metastatic Endometrial 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 Cancer 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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Dose Escalation and Dose Expansion

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Randomized for the Expansion Phase

Study Groups

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Dose Escalation

Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3447 at increasing dosage levels to determine the MTD and/or preliminary RDEs.

Group Type EXPERIMENTAL

NKT3447

Intervention Type DRUG

Oral CDK2 inhibitor

Dose Expansion

Dose expansion will include 2 RDEs selected to determine the preliminary antitumor activity and the RP2D.

Group Type EXPERIMENTAL

NKT3447

Intervention Type DRUG

Oral CDK2 inhibitor

Interventions

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NKT3447

Oral CDK2 inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have confirmed unresectable advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the Investigator.

* Measurable disease per the RECIST v1.1
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Able to swallow oral medications.

Dose Escalation(Part 1):

1. Ovarian cancer
2. Endometrial cancer
3. Gastric cancer or gastroesophageal junction cancer
4. Small cell lung cancer (SCLC)
5. Triple-negative breast cancer (human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], progesterone receptor negative)
6. ER/progesterone-receptor positive, HER2 negative breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy)
7. Other solid tumors with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy.

Dose Expansion (Part 2):

a. Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy.

* Measurable disease per the RECIST v1.1
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Able to swallow oral medications.

Exclusion Criteria

* 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
* Visceral crisis with life-threatening complications, lymphangitic spread, CNS metastasis and/or carcinomatous meningitis
* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
* Clinically active interstitial lung disease
* History of uveitis, retinopathy or other clinically significant retinal disease
* Has known human immunodeficiency virus (HIV), active hepatitis B or C infection
* Prior CDK2 inhibitor
* Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3447

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No