Cofetuzumab Pelidotin for Recurrent Non-Small Cell Lung Cancer

Not currently recruiting at 48 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called cofetuzumab pelidotin, an experimental drug, to determine its safety and effectiveness for people with non-small cell lung cancer (NSCLC) that recurs. The focus is on tumors with a specific marker, PTK7, identified through lab testing. Suitable candidates have NSCLC that has progressed after treatments like chemotherapy and immune therapy, with the cancer showing measurable growth. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticancer therapy, including chemotherapy, radiation, immunotherapy, or biologic treatments, at least 28 days before starting the study drug. However, if you are on EGFR tyrosine kinase inhibitors, you do not need a washout period. Anti-cancer herbal therapies should be stopped 7 days before the study drug.

Is there any evidence suggesting that cofetuzumab pelidotin is likely to be safe for humans?

Research has shown that Cofetuzumab Pelidotin, a new treatment being tested for recurring non-small cell lung cancer, has a safety profile that patients can handle well. One study found that patients with various types of lung cancer and genetic backgrounds tolerated the treatment effectively, suggesting it may be safe for many people.

Another study demonstrated that the treatment was effective in patients who had already tried other cancer treatments. The doses used in these studies ranged from 2.1 to 3.2 mg/kg, similar to those planned for the current trial. Overall, these findings suggest that Cofetuzumab Pelidotin is generally well-tolerated, with side effects that are usually manageable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for recurrent non-small cell lung cancer, like chemotherapy and targeted therapies, work by attacking rapidly dividing cells or specific cancer cell mutations. Cofetuzumab Pelidotin is unique because it uses an antibody-drug conjugate mechanism, which delivers a potent chemotherapy agent directly to the cancer cells. This targeted approach aims to minimize damage to healthy cells and potentially reduce side effects compared to traditional chemotherapy. Researchers are excited about this treatment because it could offer a more precise attack on the cancer, potentially improving effectiveness and tolerability for patients.

What evidence suggests that cofetuzumab pelidotin might be an effective treatment for recurrent non-small cell lung cancer?

Studies have shown that cofetuzumab pelidotin holds promise for treating recurrent non-small cell lung cancer (NSCLC). In patients with high levels of the protein PTK7, the treatment led to tumor shrinkage in about 30% of cases. Early research indicates that the drug is generally safe, with no life-threatening side effects reported. Cofetuzumab pelidotin specifically targets the PTK7 protein, often found on cancer cells, allowing it to focus on and attack the cancer. This targeted approach makes the drug a hopeful option for those with this type of lung cancer. Participants in this trial will receive cofetuzumab pelidotin to further evaluate its effectiveness and safety. ^{1 3 4 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40086026/

A phase 1b study of cofetuzumab pelidotin monotherapy in ... Treatment-related AEs were reported in 94 % of patients; none were fatal. Overall, ORR was 18 %; in patients with PTK7 expression of ≥90 % tumor cells with ≥2+ ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04189614

Study Details | NCT04189614 | An Efficacy and Safety ... 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) ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534%2823%2902678-9/fulltext

655O Phase Ib study of cofetuzumab pelidotin, an anti- ... Conclusions. Cofe-P was well-tolerated with encouraging antitumor activity observed in rNSCLC and 30% ORR in the subpopulation with NSQ EGFR WT NSCLC and PTK7 ...

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M19-611

An Efficacy and Safety Study of Cofetuzumab Pelidotin in ... 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) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9401513/

First-in-Human Study of PF-06647020 (Cofetuzumab Pelidotin ... This PTK7-targeted ADC demonstrated therapeutic activity in previously treated patients with ovarian cancer, NSCLC, and TNBC at a dose range of 2.1–3.2 mg/kg.

6. lungcancerjournal.info lungcancerjournal.info/article/S0169-5002(25)00384-8/fulltext

A phase 1b study of cofetuzumab pelidotin monotherapy in ... Herein, we report the results of a phase 1b study evaluating Cofe-P safety, efficacy, and pharmacokinetics in patients with recurrent non-small ...