Clinical trial NCT04721015: 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
Official title: A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 3 years
measure: Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Percentage of Participants With Objective Response Rate (ORR) (Part 1)
timeFrame: Up to approximately 3 years
measure: Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
timeFrame: Up to approximately 12 months
measure: Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
timeFrame: Up to approximately 20 months
measure: Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
timeFrame: Up to approximately 20 months
measure: Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
timeFrame: Up to approximately 12 months after last dose of study drug
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 231209
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 225698
state: Missouri
city: Huntersville
country: United States
facility: Carolina BioOncology Institute /ID# 225358
state: North Carolina
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145
state: Rhode Island
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics /ID# 225359
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 225693
state: Virginia
city: Wollongong
country: Australia
facility: Wollongong Hospital /ID# 228350
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Health /ID# 225638
state: Victoria
city: Marseille CEDEX 05
country: France
facility: AP-HM - Hopital de la Timone /ID# 225779
state: Bouches-du-Rhone
city: Bordeaux
country: France
facility: Institut Bergonie /ID# 225778
state: Gironde
city: Paris CEDEX 05
country: France
facility: Institut Curie /ID# 225829
state: Paris
city: Dijon
country: France
facility: Centre Georges François Leclerc /ID# 226760
city: Toulouse
country: France
facility: Institut Claudius Regaud /ID# 225780
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 225586
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 225585
state: Tel-Aviv
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 244412
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 225725
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 240821
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 240761
state: Fukuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 225724
state: Tokyo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center /ID# 231887
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 231886
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 231888
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 233774
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 226096
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 225976
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225975
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 225977
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 225978
city: Hsinchu City
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch /ID# 243610
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 225944
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 225946
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: