Clinical Trials List
Protocol NumberM19-037
NCT Number(ClinicalTrials.gov Identfier)NCT03893955
Completed
2020-04-20 - 2024-11-01
Phase I
Recruiting2
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
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Te-Chun Hsia 無
- Yu-Min Liao 無
- 陳鴻仁 無
- Chen-Teng Wu 無
- Liang-Chih Liu 無
- Yao-Chung Wu 無
- Ming-Hung Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsiang-Fong Kao 無
- Wei-Wu Chen 無
- 徐偉勛 無
- 林季宏 無
- James Chih-Hsin Yang 無
- Jih-Hsiang Lee 無
- CHAO-CHI HO CHAO-CHI HO 無
- 楊景堯 無
- 陳怡君 無
- Chong-Jen Yu 無
- JIN-YUAN SHIH 無
- 蔡子修 無
- 許嘉林 無
- YEN-TING LIN 無
- YEN-SHEN LU 無
- 廖斌志 無
- 廖唯昱 無
- 張端瑩 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Locally Advanced or Metastatic Solid Tumors
Objectives
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.
Test Drug
ABBV-927 、ABBV-368、Budigalimab (ABBV-181)
Active Ingredient
ABBV-368
ABBV-927
Budigalimab (ABBV-181)
ABBV-927
Budigalimab (ABBV-181)
Dosage Form
IVT
IVT
IVT
Dosage
N/A
N/A
N/A
Endpoints
Primary Outcome Measures :
Dose Expansion: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years following the first dose of study drug ]
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.
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 [ Time Frame: Up to approximately 6 months ]
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.
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181 [ Time Frame: Up to approximately 6 months ]
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.
Dose Expansion: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years following the first dose of study drug ]
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.
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 [ Time Frame: Up to approximately 6 months ]
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.
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181 [ Time Frame: Up to approximately 6 months ]
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.
Inclution Criteria
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.
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
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
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
The Estimated Number of Participants
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Taiwan
10 participants
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Global
150 participants
