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Monoclonal Antibodies

CPI-300 for Advanced Cancer (CPI-300 Trial)

Phase 1

Waitlist Available

Research Sponsored by Coordination Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days and additional cpi-300 treatment till disease progression or intolerability

Awards & highlights

CPI-300 Trial Summary

This trial is testing a new cancer drug, CPI-300, to see what the maximum tolerated dose is. Patients have advanced tumors and the drug is given through a vein.

Who is the study for?

This trial is for adults with advanced tumors that haven't responded to standard treatments or can't receive them. They must have a certain level of physical fitness (ECOG 0-1), good organ function, and not be pregnant or breastfeeding. Contraception use is required. Those with severe medical conditions, recent major surgery, significant nerve damage from previous treatments, bleeding disorders, serious heart issues in the past 6 months, chronic diarrhea, drug allergies or unresolved treatment toxicity are excluded.Check my eligibility

What is being tested?

The study tests CPI-300 on patients with advanced tumors using an accelerated titration method to quickly identify safe dosage levels before moving into a conventional '3 + 3' phase to find the maximum tolerated dose. Patients will receive CPI-300 through an IV infusion.See study design

What are the potential side effects?

While specific side effects of CPI-300 aren't listed here, common ones for cancer drugs given via IV include reactions at the infusion site like pain or swelling, fatigue, nausea and vomiting; blood count changes increasing infection risk; liver and kidney function changes; and potential allergic reactions.

CPI-300 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days and additional cpi-300 treatment till disease progression or intolerability

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days and additional cpi-300 treatment till disease progression or intolerability

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days and additional cpi-300 treatment till disease progression or intolerability for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events

Secondary outcome measures

Adverse Effect

Area Under the Curve (AUC)

Clinical Benefit

+1 more

CPI-300 Trial Design

1Treatment groups

Experimental Treatment

Group I: CPI-300Experimental Treatment1 Intervention

Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CPI-300

2021

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Coordination Pharmaceuticals, Inc.Lead Sponsor

5 Previous Clinical Trials

111 Total Patients Enrolled

Media Library

Tumors Clinical Trial 2023: CPI-300 Highlights & Side Effects. Trial Name: NCT04808453 — Phase 1

Frequently Asked Questions

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

What is the geographic reach of this trial?

"This research initiative is being conducted out of University Hospitals Cleveland Medical Center, Sarah Cannon Research Institute, Florida Cancer Specialists and 4 other medical sites. Specifically in the cities of Cleveland (Ohio), Nashville (Tennessee) and Lake Mary (Florida)."

Answered by AI

How many participants are undergoing treatment in this investigation?

"This trial necessitates 17 individuals who meet the required inclusion criteria. Potential participants may consider enrolling at University Hospitals Cleveland Medical Center in Ohio or Sarah Cannon Research Institute located in Tennessee."

Answered by AI

Are any additional participants being enrolled for this clinical experiment?

"This clinical trial is actively seeking participants, with information first appearing on clinicaltrials.gov on June 15th 2021 and the data being updated most recently on July 19th 2022."

Answered by AI

What potential harms are associated with CPI-300 use?

"As this is a Phase 1 trial, with limited evidence supporting safety and efficacy of CPI-300, Power estimates its relative safety to be given a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Study of CPI-300 in Patients With Advanced Tumors

2021. "Phase I Study of CPI-300 in Patients With Advanced Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04808453.