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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03893955




Registration number
NCT03893955
Ethics application status
Date submitted
27/03/2019
Date registered
28/03/2019
Date last updated
6/06/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2019-000478-45
Secondary ID [2] 0 0
M19-037
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Advanced Solid Tumors 0 0
Triple-Negative Breast Cancer (TNBC) 0 0
Non-small-cell-lung-cancer (NSCLC) 0 0
Metastatic Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-927
Treatment: Drugs - ABBV-368
Treatment: Drugs - ABBV-181
Treatment: Drugs - Carboplatin
Treatment: Drugs - Nab-paclitaxel

Experimental: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors - Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.

Experimental: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC - Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.

Experimental: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC - Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.

Experimental: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.

Experimental: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.

Experimental: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.

Experimental: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC - Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.


Treatment: Drugs: ABBV-927
Intravenous (IV) Infusion

Treatment: Drugs: ABBV-368
Intravenous (IV) Infusion

Treatment: Drugs: ABBV-181
Intravenous (IV) Infusion

Treatment: Drugs: Carboplatin
Intravenous (IV) Infusion

Treatment: Drugs: Nab-paclitaxel
Intravenous (IV) Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Expansion: Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 2 years following the first dose of study drug
Primary outcome [2] 0 0
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368
Timepoint [2] 0 0
Up to approximately 6 months
Primary outcome [3] 0 0
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181
Timepoint [3] 0 0
Up to approximately 6 months
Secondary outcome [1] 0 0
Dose-Expansion Phase: Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 2 years since the first dose of study drug
Secondary outcome [2] 0 0
Dose-Expansion Phase: Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 2 years since the first dose of study drug
Secondary outcome [3] 0 0
Maximum Serum Concentration (Cmax)
Timepoint [3] 0 0
Up to approximately 12 weeks after participant's initial dose of study drug
Secondary outcome [4] 0 0
Time to Maximum Observed Serum Concentration (Tmax)
Timepoint [4] 0 0
Up to approximately 12 weeks after participant's initial dose of study drug
Secondary outcome [5] 0 0
Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)
Timepoint [5] 0 0
Up to approximately 12 weeks after participant's initial dose of study drug
Secondary outcome [6] 0 0
Terminal Phase Elimination Half-life (t1/2)
Timepoint [6] 0 0
Up to approximately 4 weeks after participant's initial dose of study drug

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/09/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Icon Cancer Centre /ID# 224084 - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
France
State/province [12] 0 0
Loire-Atlantique
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
France
State/province [14] 0 0
Rhone
Country [15] 0 0
France
State/province [15] 0 0
Clermont Ferrand
Country [16] 0 0
Israel
State/province [16] 0 0
Tel-Aviv
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Malaga
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03893955
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03893955