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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)
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 moreTrial 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
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Who is running the clinical trial?
Compass TherapeuticsLead Sponsor
4 Previous Clinical Trials
483 Total Patients Enrolled
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