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NM6603 for Cancer

Phase 1

Recruiting

Research Sponsored by NucMito Pharmaceuticals Co. Ltd.

Eligibility Criteria Checklist

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

Must have

Have a histologically or cytologically confirmed diagnosis of advanced solid tumor

≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug to up to ~ 12 months in absence of progressive disease or unacceptable toxicity or withdrawal of consent

Awards & highlights

Study Summary

This trial tests a new drug to find safe and effective doses for cancer patients.

Who is the study for?

Adults with advanced solid tumors that have progressed despite previous treatments can join this trial. They must be over 18, able to swallow pills, and have a life expectancy of at least 12 weeks. Key health requirements include good kidney function, no serious urine test issues, an ECOG performance status of 0-2 (which measures how cancer affects daily living abilities), and adequate bone marrow reserve and liver function. Women who can get pregnant and men must agree to use birth control during the study.Check my eligibility

What is being tested?

The trial is testing NM6603's maximum tolerated dose (MTD) and recommended phase two dose (RP2D) in patients with advanced solid tumors. The goal is to find out the highest dose patients can take without severe side effects and the optimal dose for further studies.See study design

What are the potential side effects?

While specific side effects for NM6603 are not listed here, common ones for cancer drugs may include nausea, fatigue, increased risk of infection due to low blood cell counts, liver problems indicated by changes in blood tests results or kidney issues.

Eligibility Criteria

Inclusion Criteria

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

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My cancer diagnosis was confirmed through tissue or cell testing.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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My kidney function is good, with a filtration rate of 60 mL/min or more.

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My blood tests show enough white blood cells, platelets, and hemoglobin.

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My liver is functioning within the required limits.

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My cancer has grown or spread, confirmed by recent scans.

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My advanced cancer does not respond to standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug to up to ~ 12 months in absence of progressive disease or unacceptable toxicity or withdrawal of consent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug to up to ~ 12 months in absence of progressive disease or unacceptable toxicity or withdrawal of consent

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug to up to ~ 12 months in absence of progressive disease or unacceptable toxicity or withdrawal of consent for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of NM6603 in patients with advanced solid tumors

Secondary outcome measures

Efficacy of NM6603 by Objective Response Rate (ORR) via iRECIST

Efficacy of NM6603 by disease control rate (DCR) via iRECIST

Pharmacokinetics (PK) of NM6603 by AUC from time 0 to infinity (AUC0-∞)

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

NM6603, administered orally every day in 28-day cycles

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

NucMito Pharmaceuticals Co. Ltd.Lead Sponsor

Frequently Asked Questions

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

What are the implications of increasing doses for individuals?

"The safety of dose escalation was estimated to be a 1 as it is still in Phase 1 and there are only limited data supporting its efficacy."

Answered by AI

Is access to this trial available for participants at the present time?

"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical study, which was first made available on August 31st 2023, is currently recruiting participants. A total of 36 individuals need to be signed up from 2 different research sites."

Answered by AI

How many participants are currently taking part in this clinical trial?

"Affirmative. As per the details on clinicaltrials.gov, this medical trial has been live since 8/31/2023 and is in need of 36 participants from two different sites. The study was last revised on 9/13/2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study of NM6603 in Advanced Solid Tumors

2023. "A Phase 1 Study of NM6603 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046066.