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Trial record 1 of 1 for:    go30103
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Safety and Pharmacokinetics (PK) of Escalating Doses of MTIG7192A as a Single Agent and in Combination With Atezolizumab in Locally Advanced or Metastatic Tumors

This study is currently recruiting participants.
Verified September 2017 by Genentech, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02794571
First Posted: June 9, 2016
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
This first-in-human open-label, multicenter, dose-escalation study is designed to evaluate the safety, tolerability, and PK of MTIG7192A alone or in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

Condition Intervention Phase
Advanced/Metastatic Tumors Drug: Atezolizumab Drug: MTIG7192A Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MTIG7192A as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Baseline to the end of Cycle 1 (up to 21 days) ]
  • Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 [ Time Frame: From Baseline up to 90 days after last dose of study treatment or until initiation of another systemic anti-cancer therapy (up to approximately 3 years) ]
  • Number of Cycles with MTIG7192A [ Time Frame: From Baseline to last dose (up to approximately 3 years) ]
  • Dosage in Milligrams (mg) of MTIG7192A [ Time Frame: From Baseline to last dose (up to approximately 3 years) ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to MTIG7192A [ Time Frame: From Baseline to last ATA measurement; drawn pre-dose (0 hours [h]) Day 1 of Cycles 1-4, 8 (cycle = 21 days); then every eight cycles (Q8C) until/at discontinuation (DC) (up to 3 years); every 30 days thereafter up to 120 days (up to 3 years overall) ]
  • Percentage of Participants with ATAs to Atezolizumab [ Time Frame: From Baseline to last ATA measurement; drawn pre-dose (0 h) Day 1 of Cycles 1-4, 8 (cycle = 21 days); then Q8C until/at DC (up to 3 years); every 30 days thereafter up to 120 days (up to 3 years overall) ]

Secondary Outcome Measures:
  • Area Under the Concentration-Time Curve (AUC) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • AUC of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Maximum Serum Concentration (Cmax) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmax of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Minimum Serum Concentration (Cmin) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmin of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Clearance (CL) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • CL of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Volume of Distribution at Steady State (Vss) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Vss of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Progression-Free Survival (PFS) According to RECIST Version 1.1 [ Time Frame: From Baseline until disease progression (up to 3 years) ]
  • Cmax of Atezolizumab during Phase Ib Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmax of Atezolizumab during Phase Ib Expansion Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1, 4 (cycle = 21 days); on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmin of Atezolizumab during Phase Ib Stages [ Time Frame: Pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From Baseline until disease progression (up to 3 years) ]
  • Duration of Objective Response (DOR) According to RECIST Version 1.1 [ Time Frame: From Baseline until disease progression (up to 3 years) ]
  • Maximum Tolerated Dose (MTD) in mg of MTIG7192A as a Single Agent and in Combination with Atezolizumab [ Time Frame: From Baseline to the end of Cycle 1 (up to 21 days) ]

Estimated Enrollment: 300
Actual Study Start Date: May 23, 2016
Estimated Study Completion Date: September 28, 2019
Estimated Primary Completion Date: September 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase Ia Dose-Escalation Stage: MTIG7192A
Cohorts of at least 3 participants each will be treated with escalating doses of MTIG7192A to determine the MTD or maximum administered dose (MAD).
Drug: MTIG7192A
Several dose levels will be evaluated for MTIG7192A administered as a single agent and in combination with atezolizumab. MTIG7192A will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent MTIG7192A may receive combination treatment with MTIG7192A plus atezolizumab. Combination treatment may continue until disease progression or loss of clinical benefit.
Other Name: RO7092284
Experimental: Phase Ia Expansion Stage: MTIG7192A
Approximately 20 to 40 participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of MTIG7192A in different cancer types.
Drug: MTIG7192A
Several dose levels will be evaluated for MTIG7192A administered as a single agent and in combination with atezolizumab. MTIG7192A will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent MTIG7192A may receive combination treatment with MTIG7192A plus atezolizumab. Combination treatment may continue until disease progression or loss of clinical benefit.
Other Name: RO7092284
Experimental: Phase Ib Dose-Escalation Stage: MTIG7192A+Atezolizumab
Cohorts of at least 3 participants each will be treated with escalating doses of MTIG7192A in combination with a fixed dose of atezolizumab to determine the MTD or MAD.
Drug: Atezolizumab
Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle in combination with MTIG7192A. Combination treatment may continue until disease progression or loss of clinical benefit.
Other Name: MPDL3280A
Drug: MTIG7192A
Several dose levels will be evaluated for MTIG7192A administered as a single agent and in combination with atezolizumab. MTIG7192A will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent MTIG7192A may receive combination treatment with MTIG7192A plus atezolizumab. Combination treatment may continue until disease progression or loss of clinical benefit.
Other Name: RO7092284
Experimental: Phase Ib Expansion Stage: MTIG7192A+Atezolizumab
At least approximately 160 participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of MTIG7192A in combination with atezolizumab in different cancer types.
Drug: Atezolizumab
Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle in combination with MTIG7192A. Combination treatment may continue until disease progression or loss of clinical benefit.
Other Name: MPDL3280A
Drug: MTIG7192A
Several dose levels will be evaluated for MTIG7192A administered as a single agent and in combination with atezolizumab. MTIG7192A will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent MTIG7192A may receive combination treatment with MTIG7192A plus atezolizumab. Combination treatment may continue until disease progression or loss of clinical benefit.
Other Name: RO7092284

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy at least 12 weeks
  • Adequate hematologic and end organ function
  • Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
  • Confirmed availability of representative tumor specimens
  • Measurable disease according to RECIST Version 1.1

Exclusion Criteria:

  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
  • Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
  • Leptomeningeal disease
  • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on Screening chest computed tomograph (CT) scan
  • History of autoimmune disease
  • Positive human immunodeficiency virus (HIV) test
  • Active hepatitis B or C, or tuberculosis
  • Severe infection within 4 weeks prior to randomization
  • Prior allogeneic bone marrow or solid organ transplant
  • Significant cardiovascular disease
  • Known clinically significant liver disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794571


Contacts
Contact: Reference Study ID Number: GO30103 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 28 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02794571     History of Changes
Other Study ID Numbers: GO30103
2016-000944-33 ( EudraCT Number )
First Submitted: June 6, 2016
First Posted: June 9, 2016
Last Update Posted: September 22, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs


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