Advanced Solid TumorsPhase 1NCT07807956
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous ABBV-253 Moves Through the Body in Adult Participants With Advanced Solid Tumors
A Phase 1 study testing ABBV-253 in people with Advanced Solid Tumors and Non-Small Cell Lung Cancer, run by AbbVie at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer
- What is being tested?
- ABBV-253
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Sep 2026to Dec 2029
- Phase
- Phase 1
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
- Part 1 monotherapy dose escalation only: Participants with a diagnosis of a malignant solid tumor by histology (WHO criteria), including, but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), PDAC, gastroesophageal adenocarcinoma (GEA), ovarian cancer (OC), and biliary tract cancer (BTC)
- ECOG performance status of 0 or 1
- Participants with evaluable and measurable disease per RECIST Version 1.1.
Who cannot join
- History of other malignancies, with the following exceptions:
- No known active disease present within 3 years prior to first dose of study treatment and felt to be at low risk of recurrence by the treating investigator.
- Adequately treated in situ carcinoma without evidence of disease.
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin without evidence of disease.
- Participants with ovarian cancer with histologies other than high grade serous ovarian cancer including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor.
- Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy).
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids or any evidence of ILD or pneumonitis on Screening chest CT scan.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
START Midwest /ID# 283487
Grand Rapids, Michigan, 49546
- Recruiting
Carolina BioOncology Institute /ID# 283064
Huntersville, North Carolina, 28078
- Recruiting
Next Oncology Dallas /ID# 284346
Irving, Texas, 75039
About this study
Official title: A Phase 1 First-in-human, Open-label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-253 in Adult Subjects With Advanced Solid Tumors
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.
Read more
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.
- Conditions
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Being tested
- ABBV-253
- Keywords
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Biliary Tract Cancer, Head and Neck Squamous Cell Carcinoma, Ovarian Cancer, ABBV-253
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Stomach Neoplasms, Biliary Tract Neoplasms, Squamous Cell Carcinoma of Head and Neck, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-253Drug
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ABBV-253 Dose Escalation | Experimental | 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. Receives: Drug: ABBV-253 |
| Part 2: Dose Optimization - ABBV-253 Dose A | Experimental | Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose A. Receives: Drug: ABBV-253 |
| Part 2: Dose Optimization - ABBV-253 Dose B | Experimental | Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose B. Receives: Drug: ABBV-253 |
| Part 2: Dose Optimization - ABBV-253 Dose C | Experimental | Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose C. Receives: Drug: ABBV-253 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 4 years
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
12-lead resting ECG will be recorded.
Measured: 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.
Measured: Up to approximately 4 years
Secondary outcomes (14)
Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-253, ADC, total antibody, and payload
Cmax of ABBV-253 ADC, total antibody, and payload
Measured: Up to approximately 1 year
Time to Maximum Serum/Plasma Concentration (Tmax) of ABBV-253
Tmax of ABBV-253
Measured: 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
Measured: 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
Measured: Up to approximately 1 year
Incidence of Anti-Drug Antibodies (ADAs)
Incidence of Anti-Drug Antibodies (ADAs)
Measured: Up to approximately 1 year
Incidence of Neutralizing Antibodies (nAbs)
Incidence of Neutralizing Antibodies (nAbs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start14 Sep 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807956
- Sponsor's protocol ID
- M26-326
- Other IDs
- 2026-526097-17-00
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No