Can a new drug shrink advanced solid tumors?
NCT ID NCT07807956
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This early-stage trial tests an investigational drug called ABBV-253 in adults with advanced solid tumors, including lung, colorectal, and pancreatic cancers. The study aims to find safe doses and see whether the drug can shrink tumors. Participants receive the drug by infusion, and researchers monitor side effects and disease activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ABBV-253, an investigational drug given by intravenous infusion
- What this could lead to
- If ABBV-253 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not work as hoped or may cause unexpected side effects. The results will need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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