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
Verified date | June 2024 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | September 29, 2024 |
Est. primary completion date | September 29, 2024 |
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 |
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 | Paris |
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 | |
Taiwan | National Taiwan University Hospital /ID# 210993 | Taipei City | Taipei |
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 School of Medicine /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 |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Australia, France, Israel, Spain, Taiwan,
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 |
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