CancerPhase 1NCT04189614
An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
A Phase 1 study testing Cofetuzumab Pelidotin in people with Cancer and Non-small Cell Lung Cancer (NSCLC), run by AbbVie at 26 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Cofetuzumab Pelidotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 26 sitesin 6 countries
- Study dates
- 13 Feb 2020to 7 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Received ≤ 2 prior lines of systemic therapy, including no more than 1 line of systemic cytotoxic chemotherapy (≤ 3 prior lines for tumors treated with targeted agent(s) for genetic alterations, including no more than 1 line of systemic chemotherapy)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Adequate bone marrow, renal, and hepatic function per the protocol
Who cannot join
- Known uncontrolled metastases to the central nervous system (CNS). Participants with CNS metastases may be eligible provided that definitive therapy has been given, and participants are asymptomatic and off systemic steroids and anticonvulsants used for management of brain metastases for at least 2 weeks prior to the first dose of study drug
- Unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy (with the exception of alopecia or anemia)
- Has clinically significant medical condition(s) as described in the protocol
- Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days prior to the first dose of study drug (no washout period required for participants on EGFR tyrosine kinase inhibitors). Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period
- Received anti-cancer herbal therapies within 7 days prior to the first dose of study drug
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
United States12 sites
Univ of Colorado Cancer Center /ID# 215295
Aurora, Colorado, 80045
University of Alabama at Birmingham - Main /ID# 213605
Birmingham, Alabama, 35233
The Ohio State University /ID# 211088
Columbus, Ohio, 43210
Virginia Cancer Specialists - Fairfax /ID# 216427
Fairfax, Virginia, 22031
Oncology Consultants /ID# 215932
Houston, Texas, 77030-3306
University of Texas MD Anderson Cancer Center /ID# 215876
Houston, Texas, 77030
Sylvester Comprehensive Cancer Center /ID# 216433
Miami, Florida, 33136-1002
Tennessee Oncology, PLLC /ID# 215326
Nashville, Tennessee, 37203
Highlands Oncology Group, PA /ID# 215383
Springdale, Arkansas, 72762
Washington University-School of Medicine /ID# 213453
St Louis, Missouri, 63110
Duplicate_Stanford University School of Med /ID# 213450
Stanford, California, 94305-2200
Moffitt Cancer Center /ID# 215101
Tampa, Florida, 33612-9416
South Korea4 sites
CHA Bundang Medical Center /ID# 232514
Seongnam, Gyeonggido, 13496
Asan Medical Center /ID# 222280
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center /ID# 222906
Seoul, Seoul Teugbyeolsi, 06351
Yonsei University Health System Severance Hospital /ID# 222281
Seoul, 03722
Israel3 sites
Rambam Health Care Campus /ID# 217536
Haifa, 3109601
Rabin Medical Center. /ID# 217537
Petah Tikva, Central District, 4941492
The Chaim Sheba Medical Center /ID# 217538
Ramat Gan, Tel Aviv, 5265601
Spain3 sites
Hospital Universitario Vall de Hebron /ID# 215729
Barcelona, 08035
Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
Madrid, 28040
Hospital Universitario HM Sanchinarro /ID# 215102
Madrid, 28050
Japan2 sites
National Cancer Center Hospital /ID# 218536
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East /ID# 218537
Kashiwa-shi, Chiba, 277-8577
Taiwan2 sites
National Cheng Kung University Hospital /ID# 222602
Tainan, 704
Linkou Chang Gung Memorial Hospital /ID# 222603
Taoyuan City, 333
About this study
Official title: A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
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.
- Conditions
- Cancer, Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Cofetuzumab Pelidotin
- Keywords
- Non-small Cell Lung Cancer (NCSLC), PTK7-Expressing Tumor, Antibody Drug Conjugate, cofetuzumab pelidotin, ABBV-647, Cancer
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cofetuzumab PelidotinDrug
Also called ABBV-647
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Cofetuzumab Pelidotin | Experimental | Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks Receives: Drug: Cofetuzumab Pelidotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
Measured: Up to approximately 3 years
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time from the participant's first dose of study drug until death from any cause.
Measured: Up to approximately 3 years
Progression Free Survival (PFS)
PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause.
Measured: Up to approximately 3 years
Duration of Response (DOR)
DOR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression or death from any cause.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start13 Feb 2020
- Primary completion7 May 2026
- Study completion7 May 2026
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189614
- Sponsor's protocol ID
- M19-611
- Other IDs
- 2019-003472-39, 2019
- Status last verified
- May 2026
- First submitted
- 5 Dec 2019
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04189614
- Acronym / sponsor ID
- M19-611
- Conditions
- Cancer, Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Non-small Cell Lung Cancer (NCSLC), PTK7-Expressing Tumor, Antibody Drug Conjugate, cofetuzumab pelidotin, ABBV-647, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cofetuzumab Pelidotin | Experimental | Drug: Cofetuzumab PelidotinParticipants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Received ≤ 2 prior lines of systemic therapy, including no more than 1 line of systemic cytotoxic chemotherapy (≤ 3 prior lines for tumors treated with targeted agent(s) for genetic alterations, including no more than 1 line of systemic chemotherapy)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Key exclusion criteria (5 listed)
- Known uncontrolled metastases to the central nervous system (CNS). Participants with CNS metastases may be eligible provided that definitive therapy has been given, and participants are asymptomatic and off systemic steroids and anticonvulsants used for management of brain metastases for at least 2 weeks prior to the first dose of study drug
- Unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy (with the exception of alopecia or anemia)
- Has clinically significant medical condition(s) as described in the protocol
- Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days prior to the first dose of study drug (no washout period required for participants on EGFR tyrosine kinase inhibitors). Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period
- Received anti-cancer herbal therapies within 7 days prior to the first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cofetuzumab PelidotinAlso: ABBV-647Intravenous (IV) infusion | Drug | Cofetuzumab Pelidotin |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 3 years
Progression Free Survival (PFS)
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Time frame: Up to approximately 3 years
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cofetuzumab Pelidotin in people with Cancer and Non-small Cell Lung Cancer (NSCLC), run by AbbVie at 26 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, South Korea, Israel, Spain, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.