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Monoclonal Antibodies
CTX-471 + Pembrolizumab for Cancer
Phase 1
Waitlist Available
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
Must not have
Has had an allogeneic tissue transplant for Combination Arm 2
Has an active infection requiring systemic therapy for Combination Arm 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until confirmed disease progression (cr or pr) (up to 2 years)
Awards & highlights
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.
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).
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.
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I am fully active or can carry out light work.
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I have signed the consent form for this study.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received a tissue transplant from another person for my treatment.
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I am currently on medication for an active infection.
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I have or had lung inflammation that needed steroids.
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I stopped PD-1 or PD-L1 therapy due to a severe side effect.
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I haven't taken immunosuppressive drugs in the last 7 days.
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I do not have active heart issues like recent heart failure, new chest pain, or irregular heartbeats.
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My cancer has spread to my brain.
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I haven't had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.
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I have an autoimmune disease or need long-term steroids or immune-suppressing drugs.
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I have active brain metastases or carcinomatous meningitis.
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I have another cancer besides the one being treated, which has progressed or needed treatment in the last 3 years.
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I have a history of seizures.
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I have had a solid organ transplant.
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I am HIV positive, on ART, and my HIV is well-controlled.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Objective Response Rate (ORR) (Percentage of Participants With Objective Response) 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
Side effects data
From 2022 Phase 1 & 2 trial • 35 Patients • NCT0300346840%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
SORE THROAT
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg
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
112 Previous Clinical Trials
173,533 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.
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