A Phase 1 First-in-human, Open-label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-253 in Adult Subjects With Advanced Solid Tumors

Study Identifier:
M26-326
CT.gov Identifier:
NCT07807956
EudraCT Identifier:
202652609717
EU Trial (CTIS) Number:
2026-526097-17-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Gastric
Head & Neck
Solid Tumor
Digestive & Intestinal
Bile Duct
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1: ABBV-253 Dose Escalation
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Drug: 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: Drug: ABBV-253
Drug: Infusion
Drug: EXPERIMENTAL: Part 2: Dose Optimization - ABBV-253 Dose A
Drug: Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose A.
Drug: EXPERIMENTAL: Part 2: Dose Optimization - ABBV-253 Dose B
Drug: Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose B.
Drug: EXPERIMENTAL: Part 2: Dose Optimization - ABBV-253 Dose C
Drug: Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose C.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Manish Sharma
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Gastric
Head & Neck
Solid Tumor
Digestive & Intestinal
Bile Duct