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Cancer Vaccine

Dose Expansion for Gastric 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Dose Limiting Toxicity (DLT) events

Objective Response Rate (ORR)

Secondary outcome measures

Accumulation ratio (AR)

Apparent clearance (CL/F)

Apparent volume of distribution (V/F)

+11 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NiKang Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

300 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the safety considerations of increasing medication dosage for individuals?

"Due to the limited amount of data supporting safety and efficacy, our team at Power rates Dose Escalation with a score of 1 on the scale from 1 to 3. This is in line with it being a Phase 1 trial."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"The clinical trial, listed on clinicaltrials.gov as of February 1st, 2024 and updated most recently on February 9th, 2024, is presently not seeking participants. Despite this trial being closed for recruitment, there are currently a substantial number of 8989 other trials actively enrolling candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06264921.

All > Metastatic Triple Negative Breast Cancer > Sclc