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

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04721015
• Other study ID #: M20-111
• Secondary ID: 2020-004953-57
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 23, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors Cancer
• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• ABBV-637
Intravenous (IV) Infusion
• Docetaxel
Intravenous (IV) Infusion
• Osimertinib
Oral Tablets

Locations

Country	Name	City	State
Australia	Austin Health /ID# 225638	Heidelberg	Victoria
Australia	Wollongong Hospital /ID# 228350	Wollongong	New South Wales
France	Institut Bergonie /ID# 225778	Bordeaux	Gironde
France	Centre Georges François Leclerc /ID# 226760	Dijon
France	AP-HM - Hopital de la Timone /ID# 225779	Marseille CEDEX 05	Bouches-du-Rhone
France	Institut Curie /ID# 225829	Paris CEDEX 05	Paris
France	Institut Claudius Regaud /ID# 225780	Toulouse
Israel	Rambam Health Care Campus /ID# 225586	Haifa	H_efa
Israel	The Chaim Sheba Medical Center /ID# 225585	Ramat Gan	Tel-Aviv
Japan	National Cancer Center Hospital /ID# 225724	Chuo-ku	Tokyo
Japan	National Hospital Organization Kyushu Cancer Center /ID# 240761	Fukuoka-shi	Fukuoka
Japan	National Cancer Center Hospital East /ID# 225725	Kashiwa-shi	Chiba
Japan	National Hospital Organization Shikoku Cancer Center /ID# 240821	Matsuyama-shi	Ehime
Japan	NHO Nagoya Medical Center /ID# 244412	Nagoya-shi	Aichi
Korea, Republic of	National Cancer Center /ID# 231887	Goyang-si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 231886	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 231888	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 233774	Seoul	Seoul Teugbyeolsi
Spain	Hospital Universitario Vall d'Hebron /ID# 225976	Barcelona
Spain	Hospital Universitario 12 de Octubre /ID# 225977	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 225975	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda /ID# 226096	Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Victoria /ID# 225978	Malaga
Taiwan	National Taiwan University Hospital - Hsinchu branch /ID# 243610	Hsinchu City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345	Kaohsiung
Taiwan	National Cheng Kung University Hospital /ID# 225944	Tainan
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 225946	Taoyuan City
United States	Dana-Farber Cancer Institute /ID# 231209	Boston	Massachusetts
United States	Virginia Cancer Specialists - Fairfax /ID# 225693	Fairfax	Virginia
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	Washington University-School of Medicine /ID# 225698	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics /ID# 225359	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  France,  Israel,  Japan,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants With Objective Response Rate (ORR) (Part 1)	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	Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)	DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.	Up to approximately 12 months
Secondary	Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)	DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.	Up to approximately 20 months
Secondary	Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)	PFS is defined as the time from the first dose of any study drug to a documented radiographic disease progression according to RECIST version 1.1 as determined by the investigator, clinical progression or death from any cause, whichever occurs earlier.	Up to approximately 20 months
Secondary	Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)	OS is defined as the time from the first dose of any study drug until death from any cause.	Up to approximately 12 months after last dose of study drug