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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive intravenous (IV) infusion of ABBV-253, as part of the 4 year study."
  • "The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ABBV-253, an experimental drug, in adults with advanced solid tumors. It checks side effects, changes in cancer, and how the drug moves through the body. The drug is given through a vein, and the second part is only for people with non-small cell lung cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For Part 1, have a solid cancer confirmed by a tissue test. Examples include lung, colon or rectal, head and neck, pancreatic, stomach or food pipe, ovarian, and bile duct cancers.
  • Be fully active or able to walk and do light work, even if heavy activity is limited.
  • Have cancer that can be measured and checked using the study’s rules.

Who can't join

  • Have a history of another cancer, unless there has been no active disease for 3 years before the first study dose and the study doctor thinks it is unlikely to return. Some fully treated cancers that have not spread beyond where they started, and certain skin cancers with no disease remaining, are also allowed.
  • Have ovarian cancer other than the high-grade serous type.
  • Have untreated cancer that has spread to the brain or its lining. Treated cancer in these areas may be allowed if symptoms and scans have been stable for at least 14 days after treatment and steroids are not needed for brain swelling.
  • Have had interstitial lung disease or pneumonitis—types of lung inflammation—that needed steroid treatment throughout the body, or have signs of either condition on the screening chest scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

MI

NC

TX