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NCT Number: NCT07807956

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

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.

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Key information

Conditions

Advanced Solid Tumors Adnexal Diseases Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Ductal Adenocarcinoma Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-253

Drug

Infusion

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Up to approximately 4 years

    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.

  2. 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 in clinical laboratory test results like hematology and chemistry will be assessed.

  3. Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

    Time frame: Up to approximately 4 years

    Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

  4. Number of Participants with Change from Baseline in Electrocardiogram (ECG)

    Time frame: Up to approximately 4 years

    12-lead resting ECG will be recorded.

  5. Objective Response (OR)

    Time frame: Up to approximately 4 years

    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.

Secondary outcomes

  1. Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-253, ADC, total antibody, and payload

    Time frame: Up to approximately 1 year

    Cmax of ABBV-253 ADC, total antibody, and payload

  2. Time to Maximum Serum/Plasma Concentration (Tmax) of ABBV-253

    Time frame: Up to approximately 1 year

    Tmax of ABBV-253

  3. Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-253 ADC, total antibody, and payload

    Time frame: Up to approximately 1 year

    AUC of ABBV-253 ADC, total antibody, and payload

  4. Terminal Half-Life (t1/2) of ABBV-253 ADC, total antibody, and payload

    Time frame: Up to approximately 1 year

    t1/2 of ABBV-253 ADC, total antibody, and payload

  5. Incidence of Anti-Drug Antibodies (ADAs)

    Time frame: Up to approximately 1 year

    Incidence of Anti-Drug Antibodies (ADAs)

  6. Incidence of Neutralizing Antibodies (nAbs)

    Time frame: Up to approximately 1 year

    Incidence of Neutralizing Antibodies (nAbs)

  7. Duration of Response (DOR) by Investigator

    Time frame: Up to approximately 4 years

    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.

  8. Progression-Free Survival (PFS) by Investigator

    Time frame: Up to approximately 4 years

    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.

  9. Overall Survival (OS)

    Time frame: Up to approximately 4 years

    Overall survival (OS) defined as the time from the first dose of study drug to death from any cause.

  10. Disease Control (DC) by Investigator

    Time frame: Up to approximately 4 years

    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.

  11. Objective Response (OR) by Blinded Independent Central Review (BICR)

    Time frame: Up to approximately 4 years

    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..

  12. Duration of Response (DOR) by BICR

    Time frame: Up to approximately 4 years

    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.

  13. Progression-Free Survival (PFS) by BICR

    Time frame: Up to approximately 4 years

    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.

  14. Disease Control (DC) by BICR

    Time frame: Up to approximately 4 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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