NCT07807956RecruitingPhase 1
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 First-in-human, Open-label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-253 in Adult Subjects With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 14 Sept 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- AbbVie
- Diseases
- Head and neck cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07807956
- EU CT number
- 2026-526097-17-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 130
- From 14 Sept 2026 to the primary completion date, Dec 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| START Midwest /ID# 283487 Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Carolina BioOncology Institute /ID# 283064 Coordinator of this site? Confirm its status | Huntersville | United States | Recruiting |
| Next Oncology Dallas /ID# 284346 Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.