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CTX-471 + Pembrolizumab for Cancer
Study Summary
This trial will test a drug (CTX-471) alone or with pembrolizumab to treat cancer that has not responded to PD-1/PD-L1 inhibitor drugs. Two parts of the trial will assess different doses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- My liver is functioning well according to recent blood tests.I've had lung radiation over 30Gy within the last 6 months for a specific treatment.I have received a tissue transplant from another person for my treatment.I am currently on medication for an active infection.I am a male either sterile or will use birth control during and 4 months after the study.It's been over 28 days since my last PD-1/PD-L1 therapy, and over 21 days since any cancer treatment, radiotherapy, or surgery.I am willing to give fresh tumor samples before and after treatment for a study.I am fully active or can carry out light work.I have or had lung inflammation that needed steroids.I haven't taken immunosuppressive drugs in the last 7 days.I have signed the consent form for this study.I do not have active hepatitis B, hepatitis C, or HIV.I do not have active heart issues like recent heart failure, new chest pain, or irregular heartbeats.My side effects from previous cancer treatments are mild.My cancer has spread to my brain.I am a woman who cannot become pregnant or will use two forms of birth control during and after the study.I stopped PD-1 or PD-L1 therapy due to a severe side effect.I understand and can follow the study's requirements.I haven't had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.You had a hepatitis C virus (HCV) infection in the past, but now the virus cannot be detected in your body.I have an autoimmune disease or need long-term steroids or immune-suppressing drugs.I have active brain metastases or carcinomatous meningitis.My cancer progressed after treatment with a PD-1 or PD-L1 inhibitor.You have been treated with other experimental cancer drugs that work with the immune system.I have not received a live vaccine in the last 30 days.I am HBsAg positive but have been on HBV therapy for 4 weeks with an undetectable viral load.I have another cancer besides the one being treated, which has progressed or needed treatment in the last 3 years.I have a history of seizures.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.My blood tests show enough white cells, platelets, and hemoglobin.I have had a solid organ transplant.My cancer is advanced and confirmed by tissue analysis.You have a disease that can be measured using specific guidelines.I have had cancer treatment, including trial drugs, within the last 4 weeks for a specific treatment group.I am 18 years old or older.You are expected to live for more than 12 weeks.I am HIV positive, on ART, and my HIV is well-controlled.My kidneys work well enough, with a creatinine clearance over 30 mL/min.My cancer is confirmed as advanced and falls under specific types.I am a woman who can have children and have a recent negative pregnancy test.
- Group 1: Arm 1 Part 2 Dose Expansion
- Group 2: Arm 2 Part 2 Dose Expansion
- Group 3: Arm 1 Part 1 Dose Escalation
- Group 4: Arm 2 Part 1 Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the participant recruitment phase of this trial currently open?
"Affirmative, the data on clinicaltrials.gov points to this trial still being open and actively looking for recruits. It was initially posted on May 17th 2019 and last updated September 29th 2021."
What is the geographical range of this experiment?
"Presently, the clinical trial is operating from 8 different medical centres situated in Saint Louis, Hackensack and Port Saint Lucie along with 5 other sites. To reduce travel time for participants, it is beneficial to pick a facility close by."
Has CTX-471 been granted regulatory endorsement by the FDA?
"CTX-471 has received a score of 1 on the safety scale, as this is an early Phase 1 trial. This implies that there are limited data points in regards to both efficacy and safety."
How many participants are being recruited for this investigation?
"Compass Therapeutics is sponsoring a trial that necessitates 96 eligible participants. This study will be conducted in several locations, among them Washington University School of Medicine, Siteman Cancer Center (St. Louis), and Hackensack University Medical Center (Hackensack, NJ)."
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