Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors

Keywords

Non-Small Cell Lung Cancer Advanced Solid Tumors Gastroesophageal Adenocarcinoma ABBV-400 Carcinoma, Non-Small-Cell Lung Adenocarcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 c-Met overexpressing non-squamous wtEGFR or mutEGFR or history of advanced c-Met overexpressing squamous Non-Small Cell Lung Cancer (NSCLC) that have 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.
  • For Part 3 only - history of advanced histopathologically or cytologically confirmed diagnosis of c-Met overexpressing GEA that has progressed after treatment with at least:
  • 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and has not received >= 2 prior lines of cytotoxic chemotherapy regimens in the locally advanced or metastatic setting.
  • If applicable, an immune checkpoint inhibitor.
  • If applicable, human epidermal growth factor receptor 2 (HER2) directed therapy.
  • If applicable, standard of care targeted therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Laboratory values meeting the criteria outlined in the protocol.

You CAN'T join if...

Locations

  • University of California, Los Angeles /ID# 243841 accepting new patients
    Santa Monica California 90404-2125 United States
  • Univ of Colorado Cancer Center /ID# 231574 not yet accepting patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT05029882
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 190 study participants
Last Updated