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Monoclonal Antibodies
CTX-471 + Pembrolizumab for Cancer
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
Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study and for 4 months following the last dose of study treatment
Willingness to provide pre- and post-treatment fresh tumor biopsies for Monotherapy Arm 1
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 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.
Who is the study for?
Adults with certain advanced cancers (like lung, melanoma, or head and neck) that worsened after PD-1/PD-L1 inhibitor treatment can join. They must have good organ function, no recent immunosuppressants or vaccines, not be pregnant or breastfeeding, and agree to use birth control. Excluded are those with severe heart issues, active infections like hepatitis B/C or HIV unless controlled, other recent cancer treatments or live vaccines.Check my eligibility
What is being tested?
The trial is testing CTX-471 alone or with pembrolizumab in patients whose cancer progressed on PD-1/PD-L1 inhibitors. It's a Phase 1 study with two parts: first finding the right dose (escalation), then expanding to more patients at that dose (expansion).See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since both drugs work by boosting it. This could lead to inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue from the body's increased activity fighting cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male either sterile or will use birth control during and 4 months after the study.
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I am willing to give fresh tumor samples before and after treatment for a study.
Select...
I am fully active or can carry out light work.
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I have signed the consent form for this study.
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My cancer progressed after treatment with a PD-1 or PD-L1 inhibitor.
Select...
My blood tests show enough white cells, platelets, and hemoglobin.
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I am 18 years old or older.
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My kidneys work well enough, with a creatinine clearance over 30 mL/min.
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My cancer is confirmed as advanced and falls under specific types.
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I am a woman who can have children and have a recent negative pregnancy test.
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
Dose(s) of CTX 471 as a monotherapy and doses of CTX-471 in combination with pembrolizumab to be examined in Part 2 and the recommended Phase 2 dose(s)
Number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities
Secondary outcome measures
Area under the serum concentrations of CTX-471 versus time curve (AUC) for CTX-471 as a monotherapy and CTX-471 in combination with pembrolizumab
Development of anti-drug antibodies (ADAs) and/or neutralizing antibodies of CTX-471 as a monotherapy and CTX-471 in combination with pembrolizumab
Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 of CTX-471 as a monotherapy and CTX-471 in combination with pembrolizumab
+5 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm 2 Part 2 Dose ExpansionExperimental Treatment2 Interventions
Two cohorts of CTX-471 (0.3 mg/kg and 0.6 mg/kg) in combination with pembrolizumab (KEYTRUDA® ) (400 mg) in three tumor type subgroups. Cohort 1 - Group 1A - NSCLC , Group 1B -SCLC and Group 1C - Melanoma. Cohort 2 Group 2A - NSCLC, Group 2B - SCLC and Group 2C -Melanoma.
Group II: Arm 2 Part 1 Dose EscalationExperimental Treatment2 Interventions
Escalating doses of CTX-471 in combination with pembrolizumab (KEYTRUDA® ) depending on cohort at enrollment
Group III: Arm 1 Part 2 Dose ExpansionExperimental Treatment1 Intervention
Two dose groups of CTX-471 (0.3 mg/kg and 0.6 mg/kg)
Group IV: Arm 1 Part 1 Dose EscalationExperimental Treatment1 Intervention
Escalating doses of CTX-471 depending on cohort at enrollment
Find a Location
Who is running the clinical trial?
Compass TherapeuticsLead Sponsor
4 Previous Clinical Trials
381 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
169,911 Total Patients Enrolled
1 Trials studying Mesothelioma
43 Patients Enrolled for Mesothelioma
Merck, Sharp & Dohme, LLC, Rahway, NJ USAUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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)."
Answered by AI
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