← Back to Search

Anti-tumor antibiotic

Dose Escalation Cohort 1 for Hodgkin's Lymphoma

Phase 1

Recruiting

Research Sponsored by Compass Therapeutics

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 baseline until confirmed disease progression (cr or pr) (up to 2 years)

Awards & highlights

Study Summary

This trial is testing a new drug called CTX-8371 in patients with advanced cancer. The study will be done in two parts: one to find the best dose of the drug and another to

Who is the study for?

This trial is for adults with advanced cancers like breast cancer, lung cancer, or melanoma that have stopped responding to standard treatments. Participants must have tried a PD-1/PD-L1 inhibitor and, if they have a specific mutation (BRAF V600), also BRAF/MEK inhibitors.Check my eligibility

What is being tested?

The study tests CTX-8371 as a solo treatment in two parts: first finding the right dose and then seeing how well it works at that dose. It's for patients whose cancers haven't responded to other therapies.See study design

What are the potential side effects?

As this is an early-phase trial of CTX-8371, side effects are being studied; however, common side effects may include fatigue, nausea, skin reactions, or allergic responses typical of new cancer drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until confirmed disease progression (cr or pr) (up to 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline until confirmed disease progression (cr or pr) (up to 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until confirmed disease progression (cr or pr) (up to 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

Cohort 1: Determine the dose(s) of CTX-8371 to be further examined in Phase 2 studies

Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371

Cohort 2: Evaluate the safety and tolerability of CTX-8371 at dose(s) selected from Cohort 1

Secondary outcome measures

Area under the serum concentrations of CTX-8371 versus time curve (AUC) for CTX-8371

Assess the immunogenicity of CTX-8371

Clearance (CL) of serum concentrations of CTX-8371

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort 2Experimental Treatment1 Intervention

Dose of CTX-8371 depending on Cohort 1 data

Group II: Dose Escalation Cohort 1Experimental Treatment1 Intervention

Escalating doses of CTX-8371

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Compass TherapeuticsLead Sponsor

4 Previous Clinical Trials

483 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 for patient participation in this clinical trial?

"Yes, the data available on clinicaltrials.gov confirms that this research is actively enrolling participants. The study was first posted on March 19th, 2024 and last modified on March 20th, 2024. It aims to recruit a total of 55 patients from two distinct sites."

Answered by AI

How large is the overall participant pool in this medical study?

"Indeed, the information available on clinicaltrials.gov confirms that recruitment is ongoing for this research endeavor. Originally listed on March 19, 2024, with the latest update occurring on March 20, 2024, the study aims to enroll a total of 55 participants spread across two designated sites."

Answered by AI

What are the risks associated with increasing the dosage in Cohort 1 for individuals participating in this trial?

"Our organization, Power, rates the safety of Dose Escalation Cohort 1 as a level 1 on our scale. This assessment is due to the early stage of this trial (Phase 1), where there is only preliminary data supporting both effectiveness and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

2024. "A Phase 1 of CTX-8371 in Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06150664.