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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Gastric Cancer; Biliary Tract Cancer; Advanced Solid Tumors; Pancreatic Ductal Adenocarcinoma; Ovarian Cancer; Gastroesophageal Junction Adenocarcinoma; Head and Neck Squamous Cell Carcinoma; Colorectal Cancer; Non-Small Cell Lung Cancer

Treatments: Drug: ABBV-253

Study type: Interventional

Funder types: Industry

Identifiers

NCT07807956

M26-326

2026-526097-17-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 4 patient groups

Part 1: ABBV-253 Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: ABBV-253

Part 2: Dose Optimization - ABBV-253 Dose A

Experimental group

Description:

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

Treatment:

Drug: ABBV-253

Part 2: Dose Optimization - ABBV-253 Dose B

Experimental group

Description:

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

Treatment:

Drug: ABBV-253

Part 2: Dose Optimization - ABBV-253 Dose C

Experimental group

Description:

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

Treatment:

Drug: ABBV-253