A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2019-10-02
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy or for which standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Antibodies, Monoclonal; Atezolizumab

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy at least 12 weeks

• Adequate hematologic and end organ function

• Negative pregnancy test and willingness to utilize contraception among women of childbearing potential

• Locally advanced, recurrent, or metastatic incurable solid malignancy with measurable disease per RECIST v1.1

• Progression following at least one standard therapy; or standard therapy considered ineffective, intolerable, or inappropriate; or use of an investigational agent recognized as a standard of care

• For the expansion stage, histologically confirmed renal cell cancer (RCC), urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or Merkel cell cancer

• For the expansion stage, evaluable for PD-L1 expression

• Anti PD-1/PD-L1 relapsed cohorts (I and II), participants whose most recent anti-cancer therapy consisted of single-agent PD-1/PD-L1 blockade will be enrolled

Exclusion Criteria:

• Significant cardiovascular or liver disease

• Major surgery within 28 days of study drug

• Any anti-cancer therapy within 3 weeks of study drug

• Malabsorption syndrome or poor upper gastrointestinal integrity

• Primary central nervous system (CNS) malignancy or active metastases within 5 years

• Uncontrolled tumor pain

• Autoimmune disease other than stable hypothyroidism or vitiligo

• Human immunodeficiency virus (HIV), active hepatitis B or C, or tuberculosis

• Signs/symptoms of infection, or use of antibiotics within 2 weeks of study drug

• Live attenuated vaccine within 4 weeks of study drug

• Known history or predisposition to QT interval prolongation

• Prior cancer immunotherapy, specifically indoleamine 2,3-dioxygenase (IDO) or tryptophan 2,3-dioxygenase (TDO) inhibitors, T-cell costimulatory receptor agonist antibodies, or checkpoint inhibitors among certain participants