Recruiting
Phase 1

ABBV-253

Sponsor:

AbbVie

Code:

NCT07807956

Conditions

Advanced Solid Tumors

Non-Small Cell Lung Cancer

Colorectal Cancer

Pancreatic Ductal Adenocarcinoma

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-253

Study Details

Brief 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. 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.

Conditions

Advanced Solid Tumors

Non-Small Cell Lung Cancer

Colorectal Cancer

Pancreatic Ductal Adenocarcinoma

Gastric Cancer

Study ID

NCT07807956

Start date

Sep 14, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: ABBV-253 Dose Escalation

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.

experimental: Part 2: Dose Optimization - ABBV-253 Dose A

Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose A.

experimental: Part 2: Dose Optimization - ABBV-253 Dose B

Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose B.

experimental: Part 2: Dose Optimization - ABBV-253 Dose C

Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose C.

Interventions

ABBV-253

Infusion

Primary outcome measure

  • Number of Participants With Adverse Events [ Time Frame: Up to approximately 4 years ]
  • Number of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results [ Time Frame: Up to approximately 4 years ]
  • Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [ Time Frame: Up to approximately 4 years ]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Up to approximately 4 years ]
  • Objective Response (OR) [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

START Midwest /ID# 283487

Recruiting

Grand Rapids, Michigan, United States, 49546

Carolina BioOncology Institute /ID# 283064

Recruiting

Huntersville, North Carolina, United States, 28078

Next Oncology Dallas /ID# 284346

Recruiting

Irving, Texas, United States, 75039

More Information

Sponsor

AbbVie

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.