ABBV-253 in adults with advanced solid tumors
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
Run by AbbVie · NCT07807956 · Data updated 2026-11-12
This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 3 sites (Grand Rapids, Michigan and 2 other locations) |
| Status | Recruiting |
| Started | September 14, 2026 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07807956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with eligible advanced solid tumors, including NSCLC, CRC, PDAC, or gastric cancer, who have evaluable disease and a good performance status.
✕Probably not a fit
Patients with tumors not showing response or with intolerable adverse events may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, open-label study evaluating ABBV-253 in adults with various advanced solid tumors, including NSCLC, colorectal cancer, pancreatic cancer, and gastric cancer. Part 1 uses dose-escalation to establish safe and potentially active dose levels, while Part 2 focuses on dose optimization in NSCLC participants. Approximately 130 participants will receive IV infusions across about 11 sites worldwide over a four-year period, with safety, disease activity, and pharmacokinetics being monitored. The trial is sponsored by AbbVie and involves several cancer centers in the United States.
Why it matters
Potential benefit: Participants may receive a dose that could help control their cancer and gain information that could improve future treatments.
How similar studies have gone: Prior early-phase studies of targeted cancer therapies have shown safety signals and hints of activity in some solid tumors, supporting further investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
START Midwest /ID# 283487
Grand Rapids, Michigan, United States Recruiting -
Carolina BioOncology Institute /ID# 283064
Huntersville, North Carolina, United States Recruiting -
Next Oncology Dallas /ID# 284346
Irving, Texas, United States Recruiting
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.