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Monoclonal Antibodies

CAN04 for Melanoma

Phase 1

Waitlist Available

Research Sponsored by Cantargia AB

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 up to 36 months after 1st dose of last subject (or death)

Awards & highlights

Study Summary

This trial is testing a new drug in combination with pembrolizumab to see if it is safe and effective in treating certain types of cancer.

Eligible Conditions

Melanoma
Head and Neck Squamous Cell Carcinoma
Non-Small Cell Lung Cancer
Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months after 1st dose of last subject (or death)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months after 1st dose of last subject (or death)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months after 1st dose of last subject (or death) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency of TEAEs (treatment-emergent adverse events) (Part 1)

Therapeutic procedure

Number of participants with DLTs (dose-limiting toxicities) (Part 1)

+17 more

Secondary outcome measures

Antidrug antibodies (ADAs) against CAN04

Change in serum CRP (C-reactive protein) concentration (Part 1)

Change in serum CRP (C-reactive protein) concentration (Part 2)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: CAN04 and pembrolizumab (Part 1)Experimental Treatment2 Interventions

Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen

Group II: CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)Experimental Treatment4 Interventions

Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Pemetrexed

2014

Completed Phase 3

~5250

CAN04

2021

Completed Phase 1

~50

Carboplatin

2014

Completed Phase 3

~6670

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Cantargia ABLead Sponsor

5 Previous Clinical Trials

428 Total Patients Enrolled

Ignacio Garcia-Ribas, MD, PhDStudy DirectorCantargia AB

2 Previous Clinical Trials

65 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies within this research trial?

"This clinical trial is not taking new patients at this moment. Initially posted on September 24th, 2020 and last updated November 9th 2022; if you are searching for different studies, there are currently 4478 active trials pertaining to oral squamous cell carcinoma and a further 961 related specifically to CAN04 that require participants."

Answered by AI

What is the estimated risk of utilizing CAN04 as a treatment?

"Due to the limited supporting data, our team at Power assigned CAN04 a score of 1 on safety and efficacy. This is in line with its position as a Phase 1 trial."

Answered by AI

How many participants will be accepted into this experiment?

"Unfortunately, recruitment for this medical trial has concluded. This study was initially posted on September 24th 2020 and was last updated November 9th 2022. Alternatively, there are currently 4478 clinical trials actively enrolling participants with oral squamous cell carcinoma and 961 studies searching for patients participating in CAN04."

Answered by AI

Has CAN04 been tested in other clinical investigations previously?

"At present, CAN04 is the subject of over nine hundred and sixty-one trials; one hundred and twenty-two are in the third phase. While Houston, Texas is a major site for research on this medication, there are thirty five thousand seven hundred and thirty one different locations running studies related to it."

Answered by AI

To what conditions is CAN04 typically applied as a treatment?

"CAN04 is routinely administered to patients with malignant neoplasms, and may be prescribed for individuals experiencing advanced melanoma, microsatellite instability high, or who have undergone chemotherapy with limited success."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors

2020. "A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04452214.