NCT02219724

A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors

Completed Phase 1 Last updated 5 February 2020

What this trial tests

Phase 1 trial testing MOXR0916 in Neoplasms in 174 participants. Completed in 18 August 2019.

Timeline

12 August 2014

Primary endpoint
14 July 2017

18 August 2019

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	174
Start date	12 August 2014
Primary completion	14 July 2017
Estimated completion	18 August 2019
Sites	31 locations across Belgium, South Korea, Canada, Australia, United States, Spain

Drugs / interventions tested

• MOXR0916 — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →

Sponsor

Genentech, Inc. — full company profile →

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in participants with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. This study will consist of a screening period, an initial treatment period, a re-treatment period (for participants who discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage. The planned duration of the study is approximately 3 years.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PD-L1 (B7-H1) and PD-1 pathway blockade for cancer therapy: Mechanisms, response biomarkers, and combinations.
   Zou W, Wolchok JD, Chen L. · · 2016 · cited 1923× · PMID 26936508 · DOI 10.1126/scitranslmed.aad7118
2. Targeting Negative and Positive Immune Checkpoints with Monoclonal Antibodies in Therapy of Cancer.
   Marhelava K, Pilch Z, Bajor M, Graczyk-Jarzynka A, et al · · 2019 · cited 100× · PMID 31717326 · DOI 10.3390/cancers11111756
3. Harnessing the tumor microenvironment: targeted cancer therapies through modulation of epithelial-mesenchymal transition.
   Glaviano A, Lau HS, Carter LM, Lee EHC, et al · · 2025 · cited 90× · PMID 39806516 · DOI 10.1186/s13045-024-01634-6
4. Intravesical BCG Induces CD4<sup>+</sup> T-Cell Expansion in an Immune Competent Model of Bladder Cancer.
   Kates M, Nirschl T, Sopko NA, Matsui H, et al · · 2017 · cited 66× · PMID 28588015 · DOI 10.1158/2326-6066.cir-16-0267
5. New Strategies in Bladder Cancer: A Second Coming for Immunotherapy.
   Ghasemzadeh A, Bivalacqua TJ, Hahn NM, Drake CG. · · 2016 · cited 56× · PMID 26683632 · DOI 10.1158/1078-0432.ccr-15-1135
6. Targeting Cbl-b in cancer immunotherapy.
   Augustin RC, Bao R, Luke JJ. · · 2023 · cited 55× · PMID 36750253 · DOI 10.1136/jitc-2022-006007
7. Clinical application of immune checkpoints in targeted immunotherapy of prostate cancer.
   Jafari S, Molavi O, Kahroba H, Hejazi MS, et al · · 2020 · cited 54× · PMID 32006051 · DOI 10.1007/s00018-020-03459-1
8. First-In-Human Phase I Study of the OX40 Agonist MOXR0916 in Patients with Advanced Solid Tumors.
   Kim TW, Burris HA, de Miguel Luken MJ, Pishvaian MJ, et al · · 2022 · cited 48× · PMID 35699599 · DOI 10.1158/1078-0432.ccr-21-4020