Monoclonal Antibodies
CTX-471 for Mesothelioma
Hematology Oncology Associates Of The Treasure Coast, Port Saint Lucie, FL
Targeting 7 different conditionsCTX-471 +1 morePhase 1RecruitingResearch Sponsored by Compass TherapeuticsEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Monotherapy Arm 1: metastatic or locally advanced malignancies
Combination Arm 2: metastatic or locally advanced non-small cell lung, small cell lung cancer, mesothelioma, melanoma, or head and neck cancer
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline until confirmed disease progression (cr or pr) (up to 2 years)
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Mesothelioma
- Solid Tumors
- Cancer
- Non-Small Cell Lung Cancer
- Small Cell Lung Cancer
- Melanoma
- Head and Neck Cancers
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have cancer that has spread to other parts of your body or is advanced in your body.
Select...
You have advanced lung cancer, mesothelioma, melanoma, or head and neck cancer that has spread to other parts of the body or is locally advanced.
Select...
You are expected to live for more than 12 weeks.
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 2022 Phase 2 trial • 40 Patients • NCT0301808071%
Fatigue
43%
Peripheral sensory neuropathy
38%
Alopecia
38%
Headache
33%
Nausea
29%
Pain
29%
Hypothyroidism
29%
Cough
29%
Dyspnea
24%
Rash maculo-papular
24%
Constipation
19%
Diarrhea
19%
Anorexia
19%
Abdominal pain
19%
Bloating
19%
Dyspepsia
19%
Infusion related reaction
19%
Pain in extremity
14%
Edema limbs
14%
Nasal congestion
14%
Anemia
14%
Sinusitis
14%
Dehydration
14%
Hyperglycemia
14%
Hypokalemia
14%
Allergic rhinitis
10%
Hyperthyroidism
10%
Vomiting
10%
Chills
10%
Fall
10%
Hoarseness
10%
Restlessness
10%
Mucositis oral
10%
Alanine aminotransferase increased
10%
Neutrophil count decreased
10%
Dry mouth
10%
Localized edema
10%
Skin infection
10%
Aspartate aminotransferase increased
10%
Back pain
10%
Myalgia
10%
Dizziness
10%
Pneumonitis
10%
Pruritus
10%
Flushing
10%
Hot flashes
10%
Lymphedema
10%
Thromboembolic event
5%
Eye disorders - Other, specify
5%
Metabolism and nutrition disorders - Other, specify
5%
Hypoglycemia
5%
Syncope
5%
Allergic reaction
5%
Lung infection
5%
Lymph gland infection
5%
Bruising
5%
Hypoxia
5%
Hepatobiliary disorders - Other, specify
5%
Infections and infestations - Other, specify
5%
Fever
5%
Hepatobiliary disorders - Other
5%
Sneezing
5%
Insomnia
5%
Urinary frequency
5%
Epistaxis
5%
Laryngeal hemorrhage
5%
Sore throat
5%
Hepatic failure
5%
Respiratory failure
5%
Atrial flutter
5%
Alkaline phosphatase increased
5%
Gastrointestinal disorders - Other
5%
Conjunctivitis
5%
Eye disorders - Other
5%
Flashing lights
5%
Malaise
5%
Non-cardiac chest pain
5%
Infections and infestations - Other
5%
Mucosal infection
5%
Nail infection
5%
Upper respiratory infection
5%
Urinary tract infection
5%
Blood bilirubin increased
5%
Creatinine increased
5%
Platelet count decreased
5%
Hypocalcemia
5%
Hypomagnesemia
5%
Hyponatremia
5%
Hypophosphatemia
5%
Metabolism and nutrition disorders - Other
5%
Bone pain
5%
Dysgeusia
5%
Recurrent laryngeal nerve palsy
5%
Urinary incontinence
5%
Urinary tract pain
5%
Urinary urgency
5%
Postnasal drip
5%
Nail loss
5%
Nail ridging
5%
Periorbital edema
5%
Skin hyperpigmentation
5%
Hypertension
5%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Phased Pembrolizumab Regimen)
Arm B (Concurrent Pembrolizumab Regimen)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm 2 Part Dose ExpansionExperimental Treatment2 Interventions
Two dose groups of CTX-471 (to be identified in Arm 2 Part 1) in combination with pembrolizumab
Group II: Arm 2 Part 1 Dose EscalationExperimental Treatment2 Interventions
Escalating doses of CTX-471 in combination with pembrolizumab 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2015
Completed Phase 3
~5810
Find a site
Who is running the clinical trial?
Compass TherapeuticsLead Sponsor
3 Previous Clinical Trials
326 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
104 Previous Clinical Trials
170,420 Total Patients Enrolled
1 Trials studying Mesothelioma
43 Patients Enrolled for Mesothelioma
Merck, Sharp & Dohme, LLC, Rahway, NJ USAUNKNOWN
Thomas Scheutz, MD, PhDStudy Director
Compass TherapeuticsMedia Library
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