Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer Receiving Intravenous (IV) ABBV-400

• Status: Recruiting
• Trial end date: 2025-06-28
• Target enrollment: 0
• Participant gender: All

Summary

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and is associated with poor prognosis and limited treatment options. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.

ABBV-400 is an investigational drug being developed for the treatment of NSCLC. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 100 adult participants with NSCLC, or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 80-85 sites in the Dose Expansion phase worldwide.

In the Dose Escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. In the Dose Expansion arms, participants with wtEGFR NSCLC or with mutEGFR NSCLC will receive intravenous (IV) ABBV-400 monotherapy.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• Histologic malignant solid tumor diagnosis (World Health Organization [WHO] criteria).

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

• For Part 1 only - history of advanced solid tumor that has progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.

• For Part 2 only - history of advanced non-squamous wtEGFR or mutEGFR Non-Small Cell Lung Cancer (NSCLC) and are c-Met positive that has progressed after treatment per the protocol.

• Should have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

• Laboratory values meeting the criteria outlined in the protocol.

Exclusion Criteria:

• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.

• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.