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Virus Therapy

CX-801 + Pembrolizumab for Advanced Solid Tumors

Phase 1
Recruiting
Research Sponsored by CytomX Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Must not have
Recent history (within last 2 years) of localized cancers not related to the current cancer being treated
Known active central nervous system (CNS) involvement by malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

Summary

"This trial aims to test the safety and effectiveness of a new drug called CX-801 in treating advanced solid tumors. It will be tested alone and in combination with another drug called pembrolizumab

Who is the study for?
This trial is for adults with advanced solid tumors. It's the first time they're testing CX-801, alone and combined with pembrolizumab. Participants should meet certain health conditions but specific inclusion and exclusion criteria are not provided.
What is being tested?
The study tests the safety and cancer-fighting ability of a new treatment, CX-801, on its own and paired with pembrolizumab, which is already used in cancer therapy.
What are the potential side effects?
Since this is a first-in-human study for CX-801, side effects are unknown but may be similar to other cancer treatments including fatigue, nausea, immune-related reactions or infusion-related discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread and cannot be removed by surgery, and it has gotten worse after treatment.
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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a different cancer than my current one in the last 2 years.
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My cancer has spread to my brain or spinal cord.
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I haven't had cancer treatment in the last 4 weeks or 5 half-lives of the drug.
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I stopped immunotherapy because of a severe side effect.
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I have not had radiation in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the recommended Phase 2 dose (RP2D)
Safety and tolerability of CX-801 as monotherapy and combination therapy
Secondary study objectives
Disease control rate (DCR)
Duration of disease control (DODC)
Duration of response (DOR)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: CX-801 + pembrolizumabExperimental Treatment2 Interventions
Group II: CX-801Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~6070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,862 Total Patients Enrolled
CytomX TherapeuticsLead Sponsor
8 Previous Clinical Trials
884 Total Patients Enrolled
Monika Vainorius, MDStudy DirectorCytomX Therapeutics
6 Previous Clinical Trials
431 Total Patients Enrolled
~81 spots leftby Feb 2028
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