A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors

Yamagishi Chika0 sites460 target enrollmentOctober 28, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Yamagishi Chika
Enrollment: 460
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 28, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yamagishi Chika

Eligibility 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 or history of advanced squamous Non\-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least:
•\- Platinum\-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non\-squamous wtEGFR and squamous NSCLC (Parts 2i and 2iii).
•\- Platinum\-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI\[s]) for non\- squamous mutEGFR NSCLC (Part 2ii).
•\- 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.
•\- For Part 3 only \- history of advanced histopathologically or cytologically confirmed diagnosis of gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on
•\- If applicable, an immune checkpoint inhibitor.
•\- If applicable, appropriate available therapies, including HER2\-directed therapies.

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.
•\- History of clinically significant, intercurrent lung\-specific illnesses.