A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Cancer Clinical Trial

Official title:

A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03893955
• Other study ID #: M19-037
• Secondary ID: 2019-000478-45
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 21, 2019
• Est. completion date: November 12, 2023

Study information

• Verified date: February 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: November 12, 2023
• Est. primary completion date: November 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol.
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Dose-Escalation:

• Arm A: Participants with an advanced solid tumor who have progressed on standard therapies known to provide clinical benefit and/or participants who have refused or are intolerant of such therapy.
• Arm B (non-small-cell-lung-cancer [NSCLC]): Participants with histologically or cytologically confirmed NSCLC who previously progressed during or after an anti-programmed cell death (PD)-1 or PD ligand 1 (PD-L1) therapy and a platinum-based regimen in the recurrent or metastatic setting.

Dose-Expansion:

• Arm 1, 2, and 3 (triple-negative breast cancer [TNBC]): Participants with histologically or cytologically confirmed breast adenocarcinoma that is estrogen receptor/progesterone receptor/human epidermal growth factor receptor (HER)2-negative who must have disease progression during or after at least 1 systemic therapy that included a taxane in the metastatic or recurrent setting and who are treatment-naïve to immunotherapy.
• Arm 4 (TNBC): Participants with histologically or cytologically confirmed TNBC who have received no previous anti-cancer therapy for TNBC, and who are PD-L1 negative on tumor tissue by immunohistochemistry (IHC) assay.
• Arm 5 (NSCLC): Participants with histologically or cytologically confirmed NSCLC who previously progressed either during or after an anti-PD-1 or PD-L1 therapy and a platinum-based regimen in the recurrent or metastatic setting.

Exclusion Criteria:

• Has history of inflammatory bowel disease or pneumonitis.
• Has uncontrolled metastases to the central nervous system.
• Has a concurrent malignancy that is clinically significant, treatment is required, or the participant is not clinically stable.
• Has had a major surgery = 28 days prior to the first dose of study drug or the surgical wound is not fully healed.
• Has previously treated with an anti-PD- or PD-L1-targeting agent and had during the

course of their therapy:

• any immune-mediated toxicity of Grade 3 or worse severity
• treatment of the toxicity with systemic corticosteroids
• any hypersensitivity to the PD-1 or PD-L1-targeting agent
• any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Cancer
• Carcinoma, Non-Small-Cell Lung
• Metastatic Solid Tumors
• Neoplasms
• Non-small-cell-lung-cancer (NSCLC)
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer (TNBC)

Intervention

Drug:
• ABBV-927
Intravenous (IV) Infusion
• ABBV-368
Intravenous (IV) Infusion
• ABBV-181
Intravenous (IV) Infusion
• Carboplatin
Intravenous (IV) Infusion
• Nab-paclitaxel
Intravenous (IV) Infusion

Locations

Country	Name	City	State
Australia	Icon Cancer Centre /ID# 224084	South Brisbane	Queensland
France	Centre Jean Perrin /ID# 217911	Clermont Ferrand
France	Centre Leon Berard /ID# 217910	Lyon CEDEX 08	Rhone
France	AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869	Paris
France	Institut Curie /ID# 223475	Paris CEDEX 05	Ile-de-France
France	Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880	St Herblain CEDEX	Loire-Atlantique
Israel	The Chaim Sheba Medical Center /ID# 211699	Ramat Gan	Tel-Aviv
Spain	Hospital Universitario Vall d'Hebron /ID# 212804	Barcelona
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 212806	Madrid
Spain	Hospital Universitario HM Sanchinarro /ID# 212805	Madrid
Spain	Hospital Universitario Virgen de la Victoria /ID# 221671	Malaga
Taiwan	China Medical University Hospital /ID# 221090	Taichung City
Taiwan	National Taiwan University Hospital /ID# 210993	Taipei City
United States	Mary Crowley Cancer Research /ID# 210716	Dallas	Texas
United States	Duke Cancer Center /ID# 217641	Durham	North Carolina
United States	Virginia Cancer Specialists - Fairfax /ID# 210671	Fairfax	Virginia
United States	Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072	Fort Wayne	Indiana
United States	Carolina BioOncology Institute /ID# 210664	Huntersville	North Carolina
United States	Tennessee Oncology-Nashville Centennial /ID# 221400	Nashville	Tennessee
United States	Yale University /ID# 210678	New Haven	Connecticut
United States	UPMC Hillman Cancer Ctr /ID# 222747	Pittsburgh	Pennsylvania
United States	Washington University-School of Medicine /ID# 221399	Saint Louis	Missouri
United States	NEXT Oncology /ID# 210717	San Antonio	Texas
United States	St Jude Hospital dba St Joseph /ID# 211130	Santa Rosa	California
United States	Highlands Oncology Group, PA /ID# 218863	Springdale	Arkansas
United States	Moffitt Cancer Center /ID# 215037	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  France,  Israel,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Expansion: Objective Response Rate (ORR)	ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to approximately 2 years following the first dose of study drug
Primary	Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368	The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.	Up to approximately 6 months
Primary	Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181	The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.	Up to approximately 6 months
Secondary	Dose-Expansion Phase: Progression-free Survival (PFS)	PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first.	Up to approximately 2 years since the first dose of study drug
Secondary	Dose-Expansion Phase: Duration of Response (DOR)	DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first.	Up to approximately 2 years since the first dose of study drug
Secondary	Maximum Serum Concentration (Cmax)	Maximum Serum Concentration (Cmax)	Up to approximately 12 weeks after participant's initial dose of study drug
Secondary	Time to Maximum Observed Serum Concentration (Tmax)	Time to Maximum Observed Serum Concentration (Tmax)	Up to approximately 12 weeks after participant's initial dose of study drug
Secondary	Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)	Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCt).	Up to approximately 12 weeks after participant's initial dose of study drug
Secondary	Terminal Phase Elimination Half-life (t1/2)	Terminal Phase Elimination Half-life (t1/2)	Up to approximately 4 weeks after participant's initial dose of study drug