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

NCT04721015 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: M20-1112020-004953-57
• Study Type: interventional
• Target: 81
• Locations: 8 countries
• Sites: 33

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)

Keywords

Advanced Solid Tumors Cancer; Non Small Cell Lung Cancer; NSCLC; Cancer; ABBV-637; Docetaxel; Osimertinib

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  Up to approximately 3 years

• Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)

  ORR is defined as the percentage of participants with a confirmed response (CR) or partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Up to approximately 3 years

Secondary Outcomes (5)

• Percentage of Participants With Objective Response Rate (ORR) (Part 1)

  Up to approximately 3 years

• Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)

  Up to approximately 12 months

• Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)

  Up to approximately 20 months

• Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)

  Up to approximately 20 months

• Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)

  Up to approximately 12 months after last dose of study drug

Study Arms (5)

Part 1: ABBV-637 Monotherapy

EXPERIMENTAL

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

Drug: ABBV-637

Part 2a: ABBV-637 + Docetaxel

EXPERIMENTAL

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

Drug: ABBV-637; Drug: Docetaxel

Part 2b: ABBV-637 + Docetaxel

EXPERIMENTAL

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

Drug: ABBV-637; Drug: Docetaxel

Part 3a: ABBV-637 + Osimertinib

EXPERIMENTAL

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

Drug: ABBV-637; Drug: Osimertinib

Part 3b: ABBV-637 + Osimertinib

EXPERIMENTAL

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

Drug: ABBV-637; Drug: Osimertinib

Interventions

ABBV-637 DRUG

Intravenous (IV) Infusion

Part 1: ABBV-637 Monotherapy; Part 2a: ABBV-637 + Docetaxel; Part 2b: ABBV-637 + Docetaxel; Part 3a: ABBV-637 + Osimertinib; Part 3b: ABBV-637 + Osimertinib

Docetaxel DRUG

Intravenous (IV) Infusion

Part 2a: ABBV-637 + Docetaxel; Part 2b: ABBV-637 + Docetaxel

Osimertinib DRUG

Oral Tablets

Part 3a: ABBV-637 + Osimertinib; Part 3b: ABBV-637 + Osimertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (33)

Dana-Farber Cancer Institute /ID# 231209

Boston, Massachusetts, 02215, United States

Location

Washington University-School of Medicine /ID# 225698

St Louis, Missouri, 63110, United States

Location

Carolina BioOncology Institute /ID# 225358

Huntersville, North Carolina, 28078, United States

Location

Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145

Providence, Rhode Island, 02903-4923, United States

Location

South Texas Accelerated Research Therapeutics /ID# 225359

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists - Fairfax /ID# 225693

Fairfax, Virginia, 22031, United States

Location

Wollongong Hospital /ID# 228350

Wollongong, New South Wales, 2500, Australia

Location

Austin Health /ID# 225638

Heidelberg, Victoria, 3084, Australia

Location

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

Marseille, Bouches-du-Rhone, 13385, France

Location

Institut Bergonie /ID# 225778

Bordeaux, Gironde, 33000, France

Location

Institut Curie /ID# 225829

Paris, Paris, 75248, France

Location

Centre Georges François Leclerc /ID# 226760

Dijon, 21079, France

Location

Institut Claudius Regaud /ID# 225780

Toulouse, 31052, France

Location

Rambam Health Care Campus /ID# 225586

Haifa, H_efa, 3109601, Israel

Location

The Chaim Sheba Medical Center /ID# 225585

Ramat Gan, Tel Aviv, 5265601, Israel

Location

NHO Nagoya Medical Center /ID# 244412

Nagoya, Aichi-ken, 460-0001, Japan

Location

National Cancer Center Hospital East /ID# 225725

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 240821

Matsuyama, Ehime, 791-0280, Japan

Location

National Hospital Organization Kyushu Cancer Center /ID# 240761

Fukuoka, Fukuoka, 811-1395, Japan

Location

National Cancer Center Hospital /ID# 225724

Chuo-ku, Tokyo, 104-0045, Japan

Location

National Cancer Center /ID# 231887

Goyang-si, Gyeonggido, 10408, South Korea

Location

Asan Medical Center /ID# 231886

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center /ID# 231888

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 233774

Seoul, 03722, South Korea

Location

Hospital Universitario Vall d'Hebron /ID# 225976

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 225975

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre /ID# 225977

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 226096

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 225978

Málaga, Malaga, 29010, Spain

Location

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

Kaohsiung City, Kaohsiung, 807, Taiwan

Location

National Cheng Kung University Hospital /ID# 225944

Tainan, Tainan, 704, Taiwan

Location

National Taiwan University Hospital - Hsinchu branch /ID# 243610

Hsinchu, 30059, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 225946

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Docetaxel; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: February 23, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4); TW (4); IL (2); JP (5); ES (5); AU (2); FR (5); US (6)