Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

109

Study ID:

NCT04721015

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 33 Locations for this study

See Locations Near You

Dana-Farber Cancer Institute /ID# 231209
Boston Massachusetts, 02215, United States
Washington University-School of Medicine /ID# 225698
Saint Louis Missouri, 63110, United States
Carolina BioOncology Institute /ID# 225358
Huntersville North Carolina, 28078, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145
Providence Rhode Island, 02903, United States
South Texas Accelerated Research Therapeutics /ID# 225359
San Antonio Texas, 78229, United States
Virginia Cancer Specialists - Fairfax /ID# 225693
Fairfax Virginia, 22031, United States
Wollongong Hospital /ID# 228350
Wollongong New South Wales, 2500, Australia
Austin Health /ID# 225638
Heidelberg Victoria, 3084, Australia
AP-HM - Hopital de la Timone /ID# 225779
Marseille CEDEX 05 Bouches-du-Rhone, 13385, France
Institut Bergonie /ID# 225778
Bordeaux Gironde, 33000, France
Institut Curie /ID# 225829
Paris CEDEX 05 Ile-de-France, 75248, France
Centre Georges François Leclerc /ID# 226760
Dijon , 21079, France
Institut Claudius Regaud /ID# 225780
Toulouse , 31052, France
The Chaim Sheba Medical Center /ID# 225585
Ramat Gan Tel-Aviv, 52656, Israel
Rambam Health Care Campus /ID# 225586
Haifa , 31096, Israel
NHO Nagoya Medical Center /ID# 244412
Nagoya-shi Aichi, 460-0, Japan
National Cancer Center Hospital East /ID# 225725
Kashiwa-shi Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center /ID# 240821
Matsuyama-shi Ehime, 791-0, Japan
National Hospital Organization Kyushu Cancer Center /ID# 240761
Fukuoka-shi Fukuoka, 811-1, Japan
National Cancer Center Hospital /ID# 225724
Chuo-ku Tokyo, 104-0, Japan
National Cancer Center /ID# 231887
Goyang Gyeonggido, 10408, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 233774
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Asan Medical Center /ID# 231886
Seoul , 05505, Korea, Republic of
Samsung Medical Center /ID# 231888
Seoul , 06351, Korea, Republic of
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 226096
Majadahonda Madrid, 28222, Spain
Hospital Universitario Vall d'Hebron /ID# 225976
Barcelona , 08035, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 225975
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 225977
Madrid , 28041, Spain
Hospital Universitario Virgen de la Victoria /ID# 225978
Malaga , 29010, Spain
National Taiwan University Hospital - Hsinchu branch /ID# 243610
Hsinchu City , 30059, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345
Kaohsiung , 807, Taiwan
National Cheng Kung University Hospital /ID# 225944
Tainan , 704, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 225946
Taoyuan City , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

109

Study ID:

NCT04721015

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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