Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03845166 · ClinicalTrials.gov registry record · Phase 1
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
A Phase 1 study of Colorectal Cancer and Renal Cell Carcinoma, sponsored by Exelixis.
- Active
- Registry status
- Phase 1
- Development phase
- 325
- Enrollment target
- 20
- Study locations
NCT03845166: Active Phase 1 study of Colorectal Cancer and Renal Cell Carcinoma, sponsored by Exelixis.
NCT03845166 is a Phase 1 study of Colorectal Cancer and Renal Cell Carcinoma that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 325 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03845166, a Phase 1 study of Colorectal Cancer and Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Exelixis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 325 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.
Primary Outcome
To determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for further evaluation of XL092 when administered alone and in combination with immune checkpoint inhibitors (ICIs) to subjects with advanced solid tumors
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG XL092
- DRUG Avelumab
Study Locations (20)
California
- Exelixis Clinical Site #6 - Duarte
- Exelixis Clinical Site #49 - La Jolla
- Exelixis Clinical Site #7 - Los Angeles
- Exelixis Clinical Site #84 - Los Angeles
- Exelixis Clinical Site #66 - San Francisco
- Exelixis Clinical Site #71 - Stanford
Florida
- Exelixis Clinical Site #15 - Lake Mary
- Exelixis Clinical Site #24 - Miami
Georgia
- Exelixis Clinical Site #11 - Atlanta
- Exelixis Clinical Site #80 - Atlanta
Michigan
- Exelixis Clinical Site #45 - Ann Arbor
- Exelixis Clinical Site #2 - Grand Rapids
Iowa
- Exelixis Clinical Site #41 - Iowa City
Kansas
- Exelixis Clinical Site #36 - Westwood
Maine
- Exelixis Clinical Site #62 - Scarborough
Maryland
- Exelixis Clinical Site #44 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
What the registry record for NCT03845166 still lists
NCT03845166 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (79% lower).
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT03845166 names 20 study sites across 12 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03845166 about?
NCT03845166 is a clinical study titled "A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors". This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with ad...
What is the current status of trial NCT03845166?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 325 participants. The study started on 2019-03-20. Estimated completion is 2027-05-31.
What conditions does trial NCT03845166 study?
This clinical trial studies the following conditions: Colorectal Cancer, Renal Cell Carcinoma, Metastatic Castration-Resistant Prostate Cancer, Hormone Receptor-Positive Breast Carcinoma, Neoplasm Malignant.
What interventions are being tested in trial NCT03845166?
The interventions under investigation include: Atezolizumab (DRUG), XL092 (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT03845166?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03845166 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03845166's enrollment target sits among peer trials
325 104th of 381 higher than 277 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02543983 · 325 participants · Phase 2
Neurobiology of Suicide
- NCT03016819 · 325 participants · Phase 3
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
- NCT03288207 · 325 participants · NA
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
- NCT04986657 · 325 participants · NA
Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI