NCT02048709 is a Phase 1 clinical trial of GDC-0919 in Solid Tumor, sponsored by Genentech, Inc..

Who is sponsoring NCT02048709?

NCT02048709 is sponsored by Genentech, Inc..

What drugs are being tested in NCT02048709?

Interventions in NCT02048709: GDC-0919.

What condition does NCT02048709 study?

NCT02048709 studies Solid Tumor.

Is NCT02048709 still recruiting?

NCT02048709 is currently completed. Last updated 2 February 2017.

Last reviewed 2017-02-02 · How we verify

NCT02048709

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors

Completed Phase 1 Last updated 2 February 2017

What this trial tests

Phase 1 trial testing GDC-0919 in Solid Tumor in 22 participants. Completed in 1 February 2016.

Timeline

1 April 2014

Primary endpoint
1 February 2016

1 February 2016

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	1 April 2014
Primary completion	1 February 2016
Estimated completion	1 February 2016
Sites	1 location across United States

Drugs / interventions tested

GDC-0919 — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →

Sponsor

Genentech, Inc. — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of patients with dose-limiting toxicities
Time frame: 28 days
Number of dose-limiting toxicities
Time frame: 28 days
Percentage of patients with adverse events
Time frame: approximately 15 months

Sponsor's own description

This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.

Publications & conference data

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

Targeting the IDO1 pathway in cancer: from bench to bedside.
Liu M, Wang X, Wang L, Ma X, et al · · 2018 · cited 339× · PMID 30068361 · DOI 10.1186/s13045-018-0644-y
IDO1 in cancer: a Gemini of immune checkpoints.
Zhai L, Ladomersky E, Lenzen A, Nguyen B, et al · · 2018 · cited 319× · PMID 29375124 · DOI 10.1038/cmi.2017.143
Indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors in clinical trials for cancer immunotherapy.
Tang K, Wu YH, Song Y, Yu B. · · 2021 · cited 276× · PMID 33883013 · DOI 10.1186/s13045-021-01080-8
Molecular Pathways: Targeting IDO1 and Other Tryptophan Dioxygenases for Cancer Immunotherapy.
Zhai L, Spranger S, Binder DC, Gritsina G, et al · · 2015 · cited 262× · PMID 26519060 · DOI 10.1158/1078-0432.ccr-15-0420
Targeting the indoleamine 2,3-dioxygenase pathway in cancer.
Moon YW, Hajjar J, Hwu P, Naing A. · · 2015 · cited 255× · PMID 26674411 · DOI 10.1186/s40425-015-0094-9
The Role of Indoleamine-2,3-Dioxygenase in Cancer Development, Diagnostics, and Therapy.
Hornyák L, Dobos N, Koncz G, Karányi Z, et al · · 2018 · cited 243× · PMID 29445380 · DOI 10.3389/fimmu.2018.00151
Mechanisms of regulatory T cell infiltration in tumors: implications for innovative immune precision therapies.
Nishikawa H, Koyama S. · · 2021 · cited 227× · PMID 34330764 · DOI 10.1136/jitc-2021-002591
Targeting the tumor stroma for cancer therapy.
Xu M, Zhang T, Xia R, Wei Y, et al · · 2022 · cited 195× · PMID 36324128 · DOI 10.1186/s12943-022-01670-1

Verify or expand the search:

Other trials of GDC-0919

Trials testing the same drug.

NCT02471846 — A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tum · Phase 1 · completed

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Genentech, Inc. trials

Trials by the same sponsor.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas · Phase 2 · recruiting
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02048709 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 2 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02048709.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing