Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400
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- STATUS
- Recruiting
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- End date
- Jun 22, 2025
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- participants needed
- 190
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- sponsor
- AbbVie
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 advanced solid tumors. 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 190 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 biomarker-selected dose expansion arms, participants in the following c-Met overexpressing advanced solid tumor indications: c-Met-intermediate/high non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2a) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2b), c-Met low non-squamous wtEGFR NSCLC (Part 2c), squamous NSCLC (Part 2d), and GEA (Part 3) 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.
Details
| Condition | Non-Small Cell Lung Cancer, Advanced Solid Tumors, Gastroesophageal Adenocarcinoma |
|---|---|
| Treatment | ABBV-400 |
| Clinical Study Identifier | NCT05029882 |
| Sponsor | AbbVie |
| Last Modified on | 14 July 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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