Cofetuzumab Pelidotin for Recurrent Non-Small Cell Lung Cancer

Recruiting at 40 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Steroids, Anticonvulsants, others

Disqualifiers: CNS metastases, Unresolved adverse events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 years

65 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

I've had 2 or fewer treatments for my cancer, with only 1 being chemotherapy.

My lung cancer is confirmed and tests show PTK7 protein in my tumor.

My NSCLC has worsened despite having platinum chemotherapy and either immunotherapy or targeted therapy.

Exclusion Criteria

I have brain metastases but have been treated, symptom-free, and off certain medications for 2 weeks.

I have a serious health condition mentioned in the study details.

I don't have ongoing major side effects from cancer treatment, except for hair loss or anemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

Treatment Details

Interventions

• Cofetuzumab Pelidotin

Trial Overview 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.

Participant Groups

Group I: Cofetuzumab Pelidotin Experimental Treatment 1 Intervention

Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University