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Cancer Vaccine

NKT3447 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by NiKang Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Dose Escalation: Ovarian cancer, Endometrial cancer, Gastric cancer or gastroesophageal junction cancer, Small cell lung cancer, Triple-negative breast cancer, Estrogen receptor/progesterone-receptor + human epidermal growth factor receptor 2 negative (HER2-) breast cancer, Other solid tumors with CCNE1 amplification

Dose Expansion: Platinum resistant or refractory ovarian cancer with cyclin E amplification

Must not have

Prior CDK2 inhibitor, WEE1 inhibitor, or protein kinase membrane associated tyrosine/threonine 1 inhibitor

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to first determine the highest safe dose of NKT3447 for adults with advanced solid tumors. Once that is found, the trial will then test the safety and effectiveness of NKT344

Who is the study for?

Adults with advanced or metastatic solid tumors, including various types of cancer such as breast, ovarian, endometrial, stomach, and small cell lung cancer. Specifically looking for participants with CCNE1 amplified ovarian cancer for the expansion phase.

What is being tested?

NKT3447 is being tested to find out its safety and tolerability at different doses (Dose Escalation phase) and to see how well it works against certain cancers like CCNE1 amplified ovarian cancer (Expansion phase).

What are the potential side effects?

Since this is a first-in-human study for NKT3447, specific side effects are not yet known but may include typical reactions related to new cancer treatments such as nausea, fatigue, allergic reactions or other unforeseen issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer type is eligible for the dose escalation study.

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My ovarian cancer is resistant to platinum treatment and has cyclin E amplification.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I can take pills by mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with CDK2, WEE1, or PKMYT1 inhibitors.

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My solid tumor can potentially be cured with surgery, radiation, or chemotherapy.

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I still feel side effects from my previous cancer treatment, but they are mild.

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I have had eye diseases like uveitis or retinopathy.

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I have HIV or active hepatitis B or C.

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My cancer has not spread to my brain, spinal cord, or caused a severe crisis.

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I have not had major surgery in the last 2 months or minor surgery in the last 10 days.

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I have an active lung condition that affects the tissue and space around the air sacs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Dose Limiting Toxicity (DLT) events

Objective Response Rate (ORR)

Secondary study objectives

Accumulation ratio (AR)

Apparent clearance (CL/F)

Apparent volume of distribution (V/F)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

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

Group II: Dose EscalationExperimental Treatment1 Intervention

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.

0 / 12Eligibility criteria met