Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to AssessAdverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumors Cancer, Non Small Cell Lung Cancer (NSCLC)

• Registration Number: JPRN-jRCT2031210468
• Lead Sponsor: Yajima Yoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Histologic solid tumor diagnosis (Part 1).

Participants enrolled in Part 2 and Part 3(combination dose escalation and expansion) must have non-small cell lung cancer (NSCLC) epidermal growth factor receptor (EGFR)-expressing per central laboratory testing.

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

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

For Part 1 only - history of relapsed/refractory (R/R) disease that has progressed on all standard of care therapy.

For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.

For Part 3 only - history of RR NSCLC that has progressed on osimertinib

Meet the laboratory values as described in the protocol.

Exclusion Criteria

History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.

Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.

For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of Participants Experiencing Adverse Events (AEs)<br>Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response Rate (ORR) (Part 1)<br>Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1) <br>Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel (Part 2 & 3)<br>Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel (Part 2 & 3) <br>Overall Survival (OS) for ABBV-637 in Combination With Docetaxel (Part 2 & 3)