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

NCT ID: NCT04721015

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2026-02-28

Brief Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed.

ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world.

In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle.

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 a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.

Conditions

Advanced Solid Tumors Cancer; Non Small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: ABBV-637 Monotherapy

Participants will receive escalating doses of ABBV-637 in 28-day cycles.

Group Type: EXPERIMENTAL

ABBV-637

Intervention Type: DRUG

Intravenous (IV) Infusion

Part 2a: ABBV-637 + Docetaxel

Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.

Group Type: EXPERIMENTAL

ABBV-637

Intervention Type: DRUG

Intravenous (IV) Infusion

Docetaxel

Intervention Type: DRUG

Intravenous (IV) Infusion

Part 2b: ABBV-637 + Docetaxel

Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.

Group Type: EXPERIMENTAL

ABBV-637

Intervention Type: DRUG

Intravenous (IV) Infusion

Docetaxel

Intervention Type: DRUG

Intravenous (IV) Infusion

Part 3a: ABBV-637 + Osimertinib

Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.

Group Type: EXPERIMENTAL

ABBV-637

Intervention Type: DRUG

Intravenous (IV) Infusion

Osimertinib

Intervention Type: DRUG

Oral Tablets

Part 3b: ABBV-637 + Osimertinib

Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.

Group Type: EXPERIMENTAL

ABBV-637

Intervention Type: DRUG

Intravenous (IV) Infusion

Osimertinib

Intervention Type: DRUG

Oral Tablets

Interventions

ABBV-637

Intravenous (IV) Infusion

Intervention Type: DRUG

Docetaxel

Intravenous (IV) Infusion

Intervention Type: DRUG

Osimertinib

Oral Tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologic solid tumor diagnosis (Part 1).
• For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory (R/R) non-small cell lung cancer (NSCLC) participants.
• For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC participants.
• 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Dana-Farber Cancer Institute /ID# 231209

Boston, Massachusetts, United States

Washington University-School of Medicine /ID# 225698

St Louis, Missouri, United States

Carolina BioOncology Institute /ID# 225358

Huntersville, North Carolina, United States

Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145

Providence, Rhode Island, United States

South Texas Accelerated Research Therapeutics /ID# 225359

San Antonio, Texas, United States

Virginia Cancer Specialists - Fairfax /ID# 225693

Fairfax, Virginia, United States

Wollongong Hospital /ID# 228350

Wollongong, New South Wales, Australia

Austin Health /ID# 225638

Heidelberg, Victoria, Australia

AP-HM - Hopital de la Timone /ID# 225779

Marseille, Bouches-du-Rhone, France

Institut Bergonie /ID# 225778

Bordeaux, Gironde, France

Institut Curie /ID# 225829

Paris, Paris, France

Centre Georges François Leclerc /ID# 226760

Dijon, , France

Institut Claudius Regaud /ID# 225780

Toulouse, , France

Rambam Health Care Campus /ID# 225586

Haifa, H_efa, Israel

The Chaim Sheba Medical Center /ID# 225585

Ramat Gan, Tel Aviv, Israel

NHO Nagoya Medical Center /ID# 244412

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East /ID# 225725

Kashiwa-shi, Chiba, Japan

Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 240821

Matsuyama, Ehime, Japan

National Hospital Organization Kyushu Cancer Center /ID# 240761

Fukuoka, Fukuoka, Japan

National Cancer Center Hospital /ID# 225724

Chuo-ku, Tokyo, Japan

National Cancer Center /ID# 231887

Goyang-si, Gyeonggido, South Korea

Asan Medical Center /ID# 231886

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 231888

Seoul, Seoul Teugbyeolsi, South Korea

Yonsei University Health System Severance Hospital /ID# 233774

Seoul, , South Korea

Hospital Universitario Vall d'Hebron /ID# 225976

Barcelona, Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 225975

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre /ID# 225977

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 226096

Majadahonda, Madrid, Spain

Hospital Universitario Virgen de la Victoria /ID# 225978

Málaga, Malaga, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345

Kaohsiung City, Kaohsiung, Taiwan

National Cheng Kung University Hospital /ID# 225944

Tainan City, Tainan, Taiwan

National Taiwan University Hospital - Hsinchu branch /ID# 243610

Hsinchu, , Taiwan

Linkou Chang Gung Memorial Hospital /ID# 225946

Taoyuan, , Taiwan

Countries

United States; Australia; France; Israel; Japan; South Korea; Spain; Taiwan

Other Identifiers

2020-004953-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M20-111

Identifier Type: -

Identifier Source: org_study_id