A Phase 1 interventional study of ABBV-253 in Advanced Solid Tumors, Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by AbbVie. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
Among 35 studies in Carcinoma, Non-Small-Cell Lung by AbbVie — 8 open to participants now, 14 under way, 5 of them phase 3. Carcinoma, Non-Small-Cell Lung · AbbVie.
Among the 35 studies in Carcinoma, Non-Small-Cell Lung by AbbVie, this one is the 18th largest by planned enrollment of the 33 interventional ones that give a count, is one of 2 that started in 2026, is one of 20 in phase 1, reaches primary completion later than 9 of the 13 other live ones, and was the 34th registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 130 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →8 of the 35 studies in Carcinoma, Non-Small-Cell Lung by AbbVie are open now, in 12 countries. Each count lists the studies.
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →35 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2026.
Median enrollment 139 across the 33 interventional studies, 579 across the 1 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
4 of the studies in Carcinoma, Non-Small-Cell Lung by AbbVie that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03893955AbbVieA Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors | 2027-03 |
| NCT05005403AbbVieStudy to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan | 2027-07 |
| NCT06772623AbbVieStudy to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations | 2027-11 |
| NCT05029882AbbVieStudy to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab | 2027-11 |
Among the 35 studies in Carcinoma, Non-Small-Cell Lung by AbbVie, from their registry updates:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events, change in disease activity and pharmacokinetics of ABBV-253.
ABBV-253 is an investigational drug being developed for the treatment of advanced solid tumors. This open-label study consists of two parts. In Part 1 (ABBV-253 dose escalation), participants with any of the eligible cancer types will receive 1 of 4 (or more) doses of ABBV-253. Each cohort receives a higher dose, lower dose, or the same dose of ABBV-253 than the previous group. In Part 2 (ABBV-253 dose optimization), a new group of participants with NSCLC will be randomly put into pre-determined dose groups to receive 1 of 3 doses of ABBV-253. Approximately 130 participants will be enrolled in the study at approximately 11 sites worldwide.
Participants will receive intravenous (IV) infusion of ABBV-253, as part of the 4 year study.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History of other , with the following exceptions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), pancreatic ductal adenocarcinoma cancer (PDAC), gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC) and ovarian cancer (OC) will receive escalating doses of ABBV-253 monotherapy.
Drug: ABBV-253
Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose A.
Drug: ABBV-253
Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose B.
Drug: ABBV-253
Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose C.
Drug: ABBV-253
Infusion
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Safety will be evaluated based upon the assessment of all-grade AEs, and SAEs reported during the treatment-emergent period, as well as clinical laboratory parameters (e.g., hematology, chemistry), vital sign measurements, and ECG results.
Time frame: Up to approximately 4 years
Number of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
Number of participants with abnormal change in clinical laboratory test results like hematology and chemistry will be assessed.
Time frame: Up to approximately 4 years
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time frame: Up to approximately 4 years
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
12-lead resting ECG will be recorded.
Time frame: Up to approximately 4 years
Objective Response (OR)
Objective Response (OR) defined as achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigators.
Time frame: Up to approximately 4 years
Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-253, ADC, total antibody, and payload
Cmax of ABBV-253 ADC, total antibody, and payload
Time frame: Up to approximately 1 year
Time to Maximum Serum/Plasma Concentration (Tmax) of ABBV-253
Tmax of ABBV-253
Time frame: Up to approximately 1 year
Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-253 ADC, total antibody, and payload
AUC of ABBV-253 ADC, total antibody, and payload
Time frame: Up to approximately 1 year
Terminal Half-Life (t1/2) of ABBV-253 ADC, total antibody, and payload
t1/2 of ABBV-253 ADC, total antibody, and payload
Time frame: Up to approximately 1 year
Incidence of Anti-Drug Antibodies (ADAs)
Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Up to approximately 1 year
Incidence of Neutralizing Antibodies (nAbs)
Incidence of Neutralizing Antibodies (nAbs)
Time frame: Up to approximately 1 year
Duration of Response (DOR) by Investigator
Duration of response (DOR) is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to approximately 4 years
Progression-Free Survival (PFS) by Investigator
PFS per RECIST v1.1 as assessed by investigator, defined as the time from the first dose of study drug to the first documentation of disease progression or death from any cause.
Time frame: Up to approximately 4 years
Overall Survival (OS)
Overall survival (OS) defined as the time from the first dose of study drug to death from any cause.
Time frame: Up to approximately 4 years
Disease Control (DC) by Investigator
Disease Control (DC) defined as best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) lasting at least 11 weeks following first study treatment, per investigator according to RECIST version 1.1.
Time frame: Up to approximately 4 years
Objective Response (OR) by Blinded Independent Central Review (BICR)
Objective Response (OR) defined as achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigators..
Time frame: Up to approximately 4 years
Duration of Response (DOR) by BICR
Duration of response (DOR) is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to approximately 4 years
Progression-Free Survival (PFS) by BICR
Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time frame: Up to approximately 4 years
Disease Control (DC) by BICR
Disease Control (DC) is defined as best overall response of confirmed CR or confirmed PR, or SD lasting at least 11 weeks following first study treatment, according to RECIST version 1.1.
Time frame: Up to approximately 4 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2029, 39 months after the start.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 39 months is below that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Carcinoma, Non-Small-Cell Lung →