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CB-03-10 for Advanced Cancers

Phase < 1
Recruiting
Research Sponsored by Cosmo Technologies Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Part 1 (Dose Escalation): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor, not amenable to standard therapy
For Part 2 (Dose Expansion): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor limited to a specific tumor subtype as determined by the SRC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days
Awards & highlights

Study Summary

This trial is testing a new drug, CB-03-10, to see if it is safe and effective in treating cancer. The trial has two parts. In the first part, doses of the drug are given to a small group of people to see what the best dose is. In the second part, the drug is given to a larger group of people with different types of cancer to see how well it works.

Who is the study for?
Adults over 18 with advanced solid tumors that can't be treated with standard therapy may join. They must have a performance status indicating they're still fairly active, proper organ function, and for women of childbearing age, a negative pregnancy test and use of birth control. People are excluded if they have autoimmune diseases, serious heart issues, uncontrolled high blood pressure, recent major surgery or radiation, recent other cancer treatments, hepatitis B/C or HIV infections.Check my eligibility
What is being tested?
The trial is testing different doses of an oral drug called CB-03-10 in two parts: first to find the highest dose patients can take without severe side effects (MTD) and then to see how well it works at that dose (RP2D). Patients will be monitored regularly for their body's response to the drug and any changes in their tumors.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical reactions might include nausea, fatigue, allergic reactions or skin rash due to new medication. The study aims to identify these by starting with lower doses and watching how participants react as the amount increases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or didn’t respond to treatment and can't be treated with standard methods.
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My cancer has returned or didn’t respond to treatment and is now advanced or has spread.
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I can take care of myself and am up and about more than half of my waking hours.
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My kidney, liver, and bone marrow are functioning well according to recent tests.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the dose-limiting toxicity
Determine the maximum tolerated dose
Secondary outcome measures
Determine a recommended Phase 2 dose (RP2D) of CB-03-10

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Part 1 (Dose Escalation): 100 mg daily.

Find a Location

Who is running the clinical trial?

Cosmo Technologies LtdLead Sponsor
13 Previous Clinical Trials
3,131 Total Patients Enrolled

Media Library

CB-03-10 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03863145 — Phase < 1
Solid Tumors Research Study Groups: 1
Solid Tumors Clinical Trial 2023: CB-03-10 Highlights & Side Effects. Trial Name: NCT03863145 — Phase < 1
CB-03-10 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03863145 — Phase < 1

Frequently Asked Questions

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

Are there any vacancies available for this medical trial?

"Per the information found on clinicaltrials.gov, this experiment is currently not enrolling participants. This trial was initially posted on June 14th 2022 and last updated on June 30th of the same year. While enrollment for this study has ceased, there are 2380 other trials that still need volunteers at present time."

Answered by AI

What is the main purpose of this research endeavor?

"This clinical trial aims to identify the greatest amount of dose that can be tolerated over a period of 28 days. Secondary objectives encompass determining activity response rate, peak plasma concentration of CB-03-10 metabolite CB-03-05 and progression free survival for patients with pancreatic adenocarcinoma, prostate adenocarcinoma or triple negative breast cancer."

Answered by AI

In which venues are the research procedures taking place?

"This trial is running at 6 different sites, situated in Colorado Springs, New Haven and Michigan Center as well as 3 other locales. It's advisable to pick the site nearest you so that travel requirements are minimal if you decide to participate."

Answered by AI
Recent research and studies
~43 spots leftby Jan 2026