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

  • STATUS
    Recruiting
  • End date
    Nov 27, 2023
  • participants needed
    150
  • sponsor
    AbbVie
Updated on 1 August 2021
paclitaxel
systemic therapy
estrogen
breast cancer
growth factor
treatment regimen
progesterone
carboplatin
immunohistochemistry
epidermal growth factor receptor
EGFR
pd-l1
cancer treatment
primary cancer
cancer chemotherapy
adenocarcinoma
solid tumour
solid tumor
progesterone receptor
epidermal growth factor
estrogen receptor
breast adenocarcinoma
solid neoplasm
taxane
advanced malignant solid tumor

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.

Details
Condition Non-Small Cell Lung Cancer, Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Cancer/Tumors, Advanced Solid Tumors, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Ewing's Family Tumors, Brain Function, Metastatic Solid Tumors, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Cancer (Pediatric), Metastatic Triple-Negative Breast Cancer, Neoplasms, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, nsclc
Treatment docetaxel, carboplatin, Nab-paclitaxel, ABBV-927, ABBV-181, ABBV-368
Clinical Study IdentifierNCT03893955
SponsorAbbVie
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

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-nave 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
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