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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Colorectal Cancer; Ovarian Cancer; Non-Small Cell Lung Cancer; Advanced Solid Tumors; Head and Neck Squamous Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Biliary Tract Cancer; Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: ABBV-253

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: ABBV-253; Infusion
Experimental: Part 2: Dose Optimization - ABBV-253 Dose A; Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose A.	Drug: ABBV-253; Infusion
Experimental: Part 2: Dose Optimization - ABBV-253 Dose B; Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose B.	Drug: ABBV-253; Infusion
Experimental: Part 2: Dose Optimization - ABBV-253 Dose C; Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose C.	Drug: ABBV-253; Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to approximately 4 years
Number of Participants with Change from Baseline in Electrocardiogram (ECG)	12-lead resting ECG will be recorded.	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.	Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-253, ADC, total antibody, and payload	Cmax of ABBV-253 ADC, total antibody, and payload	Up to approximately 1 year
Time to Maximum Serum/Plasma Concentration (Tmax) of ABBV-253	Tmax of ABBV-253	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	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	Up to approximately 1 year
Incidence of Anti-Drug Antibodies (ADAs)	Incidence of Anti-Drug Antibodies (ADAs)	Up to approximately 1 year
Incidence of Neutralizing Antibodies (nAbs)	Incidence of Neutralizing Antibodies (nAbs)	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.	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.	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.	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.	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..	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.	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.	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.	Up to approximately 4 years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; Gastric Cancer; Colorectal Cancer; Ovarian Cancer; Pancreatic Ductal Adenocarcinoma; Advanced Solid Tumors; Head and Neck Squamous Cell Carcinoma; Biliary Tract Cancer; Gastroesophageal Junction Adenocarcinoma; ABBV-253
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Stomach Neoplasms; Biliary Tract Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: M26-326; 2026-526097-17-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No