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Monoclonal Antibodies

Cofetuzumab Pelidotin for Recurrent Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed non-small cell lung cancer (NSCLC) with PTK7-expressing tumor using an immunohistochemistry (IHC) assay previously validated at a designated laboratory
Recurrent NSCLC that has progressed after treatment with at least the following approved therapies with demonstrated clinical benefit: a platinum-based chemotherapy doublet and an immune checkpoint inhibitor for tumors without targetable genetic alterations; a platinum-based chemotherapy doublet and targeted agent(s) for tumors with targeted genetic alterations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Summary

This trial is testing a new drug to treat a certain type of lung cancer that has come back.

Who is the study for?
This trial is for adults with a specific type of lung cancer (NSCLC) that has come back after treatment. They should have tried no more than two systemic therapies, one being chemotherapy and the other an immune checkpoint inhibitor or targeted agent depending on genetic alterations in their tumor. Participants must be relatively healthy and active (ECOG 0-1), have measurable disease, good organ function, and not have serious unresolved side effects from previous cancer treatments.
What is being tested?
The study tests the effectiveness and safety of Cofetuzumab Pelidotin in patients whose NSCLC expresses PTK7 protein. It's aimed at those who've seen their cancer return despite having undergone standard treatments including platinum-based chemo and either immunotherapy or targeted therapy based on genetic changes in their tumors.
What are the potential side effects?
While specific side effects for Cofetuzumab Pelidotin are not listed here, similar drugs often cause fatigue, nausea, allergic reactions, blood count changes increasing infection risk, liver or kidney issues. Side effects can vary widely between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is confirmed and tests show PTK7 protein in my tumor.
Select...
My NSCLC has worsened despite having platinum chemotherapy and either immunotherapy or targeted therapy.
Select...
I can carry out all my daily activities without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Duration of Response (DOR)
Overall Survival (OS)
Progression Free Survival (PFS)

Side effects data

From 2019 Phase 1 trial • 138 Patients • NCT02222922
80%
Alopecia
60%
Constipation
50%
Fatigue
50%
Decreased appetite
40%
Abdominal pain
40%
Weight decreased
40%
Arthralgia
40%
Headache
40%
Neutropenia
40%
Myalgia
30%
Diarrhoea
30%
Muscle spasms
30%
Pain in extremity
30%
Neuropathy peripheral
30%
Nausea
20%
Anaemia
20%
Palpitations
20%
Vomiting
20%
Aspartate aminotransferase increased
20%
Dehydration
20%
Hypokalaemia
20%
Back pain
20%
Bone pain
20%
Depression
20%
Pruritus
20%
Hypophosphataemia
20%
Insomnia
20%
Alanine aminotransferase increased
20%
Dysgeusia
20%
Peripheral sensory neuropathy
10%
Candida infection
10%
Pulmonary embolism
10%
Ear pain
10%
Neutropenic infection
10%
Lacrimation increased
10%
Oedema peripheral
10%
Urinary tract infection
10%
Fall
10%
Hypomagnesaemia
10%
Nasal congestion
10%
Pleural effusion
10%
Dermatitis acneiform
10%
Night sweats
10%
Inappropriate antidiuretic hormone secretion
10%
Eye irritation
10%
Abdominal discomfort
10%
Abdominal distension
10%
Abdominal pain lower
10%
Frequent bowel movements
10%
Gingival bleeding
10%
Intestinal obstruction
10%
Oral pain
10%
Proctalgia
10%
Rectal haemorrhage
10%
Ankle fracture
10%
Hypoalbuminaemia
10%
Iron deficiency
10%
Joint instability
10%
Hyperaesthesia
10%
Peripheral sensorimotor neuropathy
10%
Restlessness
10%
Urinary retention
10%
Oropharyngeal pain
10%
Rhinorrhoea
10%
Rash erythematous
10%
Skin hyperpigmentation
10%
Orthostatic hypotension
10%
Thrombocytopenia
10%
Musculoskeletal pain
10%
Lethargy
10%
Ascites
10%
Atrial fibrillation
10%
Otitis media
10%
Malnutrition
10%
Presyncope
10%
Dizziness
10%
Dry eye
10%
Vision blurred
10%
Abdominal pain upper
10%
Dyspepsia
10%
Hyponatraemia
10%
Anxiety
10%
Catheter site pain
10%
Oedema
10%
Haematuria
10%
Productive cough
10%
Throat irritation
10%
Acne
10%
Dry skin
10%
Flatulence
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06647020 2.8 mg/kg (Q2W Regimen)
PF-06647020 0.2 mg/kg (Q3W Regimen)
PF-06647020 0.5 mg/kg (Q3W Regimen)
PF-06647020 1.25 mg/kg (Q3W Regimen)
PF-06647020 2.1 mg/kg (Q3W Regimen)
PF-06647020 2.8 mg/kg (Q3W Regimen)
PF-06647020 3.7 mg/kg (Q3W Regimen)
PF-06647020 2.1 mg/kg (Q2W Regimen)
PF-06647020 3.2 mg/kg (Q2W Regimen)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cofetuzumab PelidotinExperimental Treatment1 Intervention
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,625 Previous Clinical Trials
14,284,129 Total Patients Enrolled
AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,713 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,556 Total Patients Enrolled

Media Library

Cofetuzumab Pelidotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04189614 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Cofetuzumab Pelidotin
Non-Small Cell Lung Cancer Clinical Trial 2023: Cofetuzumab Pelidotin Highlights & Side Effects. Trial Name: NCT04189614 — Phase 1
Cofetuzumab Pelidotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04189614 — Phase 1
~3 spots leftby Dec 2024
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