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A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (STELLAR-001)

Primary Purpose

Neoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
XL092
Atezolizumab
Avelumab
Sponsored by
Exelixis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Malignant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cytologically or histologically confirmed solid tumor that is inoperable locally advanced, metastatic, or recurrent.
  • Dose-escalation (single-agent and combination therapy): Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.
  • Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
  • Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standard of care chemotherapy regimens as prior therapy for metastatic CRC:

    • Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF monoclonal antibody (bevacizumab)
    • Anti-EGFR monoclonal antibody (cetuximab or panitumumab)
    • BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations
  • Expansion Cohort I (UC, Maintenance Therapy): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who received first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin.
  • Expansion Cohort J (UC, ICI-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after PD-1/PD-L1 targeting ICI therapy.
  • Expansion Cohort K (UC, platinum-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after first-line platinum-based combination therapy.
  • Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1, with exception of Cohort I (UC, Maintenance Therapy).
  • Tumor tissue material:

    • Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained.
  • Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • Adequate organ and marrow function.
  • Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception.
  • Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

  • Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, H, I, and K only), prior treatment with avelumab (Cohort J only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only).
  • Receipt of any type of small molecule kinase inhibitor within 2 weeks before first dose of study treatment.
  • Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before first dose of study treatment.
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
  • Uncontrolled, significant intercurrent or recent illness.
  • Concomitant use of certain medications.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 450 ms for males and > 470 ms for females. Single ECGs are no longer permitted.
  • Pregnant or lactating females.
  • Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.

Additional Exclusion Criteria for XL092 + Atezolizumab Combination Therapy Cohorts ONLY:

  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
  • Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

Additional Exclusion Criteria for XL092 + Avelumab Combination Therapy Cohorts ONLY:

  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

Sites / Locations

  • Exelixis Clinical Site #6Recruiting
  • Exelixis Clinical Site #49Recruiting
  • Exelixis Clinical Site #7Recruiting
  • Exelixis Clinical #71Recruiting
  • Exelixis Clinical Site #66Recruiting
  • Exelixis Clinical Site #15Recruiting
  • Exelixis Clinical Site #24Recruiting
  • Exelixis Clinical Site #11
  • Exelixis Clinical Site #41Recruiting
  • Exelixis Clinical Site #36Recruiting
  • Exelixis Clinical Site #62Recruiting
  • Exelixis Clinical Site #44
  • Exelixis Clinical Site #4Recruiting
  • Exelixis Clinical Site #45Recruiting
  • Exelixis Clinical Site #2Recruiting
  • Exelixis Clinical Site #25
  • Exelixis Clinical Site #13Recruiting
  • Exelixis Clinical Site #9Recruiting
  • Exelixis Clinical Site #35Recruiting
  • Exelixis Clinical #78Recruiting
  • Exelixis Clinical #74Recruiting
  • Exelixis Clinical Site #60Recruiting
  • Exelixis Clinical Site #59Recruiting
  • Exelixis Clinical Site #58Recruiting
  • Exelixis Clinical Site #12Recruiting
  • Exelixis Clinical Site #61Recruiting
  • Exelixis Clinical Site #50Recruiting
  • Exelixis Clinical Site #33Recruiting
  • Exelixis Clinical Site #3Recruiting
  • Exelixis Clinical Site #1Recruiting
  • Exelixis Clinical Site #5Recruiting
  • Exelixis Clinical Site #8Recruiting
  • Exelixis Clinical Site #43Recruiting
  • Exelixis Clinical Site #26Recruiting
  • Exelixis Clinical Site #52Recruiting
  • Exelixis Clinical Site #53Recruiting
  • Exelixis Clinical #75Recruiting
  • Exelixis Clinical Site #56Recruiting
  • Exelixis Clinical Site #63Recruiting
  • Exelixis Clinical Site #44Recruiting
  • Exelixis Clinical Site #51Recruiting
  • Exelixis Clinical Site #65Recruiting
  • Exelixis Clinical Site #21Recruiting
  • Exelixis Clinical Site #42Recruiting
  • Exelixis Clinical Site #10Recruiting
  • Exelixis Clinical Site #27Recruiting
  • Exelixis Clinical Site #46Recruiting
  • Exelixis Clinical Site #37Recruiting
  • Exelixis Clinical #72Recruiting
  • Exelixis Clinical Site #32Recruiting
  • Exelixis Clinical Site #48Recruiting
  • Exelixis Clinical Site #14Recruiting
  • Exelixis Clinical Site #39Recruiting
  • Exelixis Clinical Site #47Recruiting
  • Exelixis Clinical Site #22Recruiting
  • Exelixis Clinical Site #57Recruiting
  • Exelixis Clinical #77Recruiting
  • Exelixis Clinical Site #38Recruiting
  • Exelixis Clinical Site #28Recruiting
  • Exelixis Clinical Site #31Recruiting
  • Exelixis Clinical Site #64Recruiting
  • Exelixis Clinical Site #67Recruiting
  • Exelixis Clinical Site #69Recruiting
  • Exelixis Clinical Site #54Recruiting
  • Exelixis Clinical #73Recruiting
  • Exelixis Clinical Site #79Recruiting
  • Exelixis Clinical #76Recruiting
  • Exelixis Clinical Site #23Recruiting
  • Exelixis Clinical Site #20Recruiting
  • Exelixis Clinical Site #18Recruiting
  • Exelixis Clinical Site #19Recruiting
  • Exelixis Clinical Site #29Recruiting
  • Exelixis Clinical Site #30Recruiting
  • Exelixis Clinical Site #34Recruiting
  • Exelixis Clinical Site #55Recruiting
  • Exelixis Clinical Site #17Recruiting
  • Exelixis Clinical Site #16Recruiting
  • Exelixis Clinical #70Recruiting
  • Exelixis Clinical Site #40Recruiting
  • Exelixis Clinical Site #68Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

XL092 Single-Agent Dose-Escalation Cohorts

XL092 Single-Agent Expansion Cohorts

XL092 + Atezolizumab Dose-Escalation Cohorts

XL092 + Atezolizumab Expansion Cohorts

XL092 + Avelumab Dose-Escalation Cohorts

Arm Description

Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.

The MTD or recommended dose from the dose-escalation stage may be further explored in clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), and metastatic castration-resistant prostate cancer (mCRPC).

Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.

The MTD or recommended dose from the dose-escalation stage may be further explored in non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC).

Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.

Outcomes

Primary Outcome Measures

Dose-Escalation Stage: MTD/recommended dose for XL092
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
Cohort-Expansion Stage: Objective Response Rate (ORR)
To evaluate preliminary efficacy of XL092 when administered alone and in combination with ICIs by estimating ORR as assessed by the Investigator per RECIST 1.1
Cohort-Expansion Stage (except Cohort H): Progression-Free Survival (PFS)
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with ICIs for specific cohorts by estimating the percentage of subjects with PFS at 6 months (PFS rate) per RECIST 1.1 as assessed by the Investigator
Cohort-Expansion Stage (Cohort H only): Overall Survival (OS)
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with atezolizumab for subjects with RAS wild-type CRC (Cohort H Treatment Arms H-A and H-B) by estimating overall survival (OS)

Secondary Outcome Measures

Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety of XL092 when administered alone and in combination with ICIs through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), and adverse events of special interest (AESIs)
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax)
To evaluate the Tmax of XL092 alone and in combination with ICI
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax)
To evaluate the Cmax of XL092 alone and in combination with ICI
Dose-Escalation Stage: Area Under the Plasma Concentration-Time Curve Over the Last 24-hour Dosing Interval (AUC 0-24)
To evaluate the AUC 0-24 of XL092 alone and in combination with ICI
Dose-Escalation Stage: Terminal Half-Life
To evaluate the terminal half-life of XL092 alone and in combination with ICI
Dose-Escalation Stage: Apparent Clearance (CL/F)
To evaluate the CL/F of XL092 alone and in combination with ICI

Full Information

First Posted
February 15, 2019
Last Updated
July 21, 2023
Sponsor
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT03845166
Brief Title
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
Acronym
STELLAR-001
Official Title
A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exelixis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Castration-resistant Prostate Cancer, Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
single-agent and combination therapy dose-escalation followed by cohort-expansion
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
921 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XL092 Single-Agent Dose-Escalation Cohorts
Arm Type
Experimental
Arm Description
Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.
Arm Title
XL092 Single-Agent Expansion Cohorts
Arm Type
Experimental
Arm Description
The MTD or recommended dose from the dose-escalation stage may be further explored in clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), and metastatic castration-resistant prostate cancer (mCRPC).
Arm Title
XL092 + Atezolizumab Dose-Escalation Cohorts
Arm Type
Experimental
Arm Description
Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.
Arm Title
XL092 + Atezolizumab Expansion Cohorts
Arm Type
Experimental
Arm Description
The MTD or recommended dose from the dose-escalation stage may be further explored in non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC).
Arm Title
XL092 + Avelumab Dose-Escalation Cohorts
Arm Type
Experimental
Arm Description
Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.
Intervention Type
Drug
Intervention Name(s)
XL092
Intervention Description
oral doses of XL092
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq®
Intervention Description
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
Intervention Type
Drug
Intervention Name(s)
Avelumab
Other Intervention Name(s)
Bavencio®
Intervention Description
Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)
Primary Outcome Measure Information:
Title
Dose-Escalation Stage: MTD/recommended dose for XL092
Description
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
Time Frame
Up to 24 months
Title
Cohort-Expansion Stage: Objective Response Rate (ORR)
Description
To evaluate preliminary efficacy of XL092 when administered alone and in combination with ICIs by estimating ORR as assessed by the Investigator per RECIST 1.1
Time Frame
Up to 24 months
Title
Cohort-Expansion Stage (except Cohort H): Progression-Free Survival (PFS)
Description
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with ICIs for specific cohorts by estimating the percentage of subjects with PFS at 6 months (PFS rate) per RECIST 1.1 as assessed by the Investigator
Time Frame
Up to 24 months
Title
Cohort-Expansion Stage (Cohort H only): Overall Survival (OS)
Description
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with atezolizumab for subjects with RAS wild-type CRC (Cohort H Treatment Arms H-A and H-B) by estimating overall survival (OS)
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
To evaluate the safety of XL092 when administered alone and in combination with ICIs through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), and adverse events of special interest (AESIs)
Time Frame
Up to 36 months
Title
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax)
Description
To evaluate the Tmax of XL092 alone and in combination with ICI
Time Frame
Up to 24 months
Title
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax)
Description
To evaluate the Cmax of XL092 alone and in combination with ICI
Time Frame
Up to 24 months
Title
Dose-Escalation Stage: Area Under the Plasma Concentration-Time Curve Over the Last 24-hour Dosing Interval (AUC 0-24)
Description
To evaluate the AUC 0-24 of XL092 alone and in combination with ICI
Time Frame
Up to 24 months
Title
Dose-Escalation Stage: Terminal Half-Life
Description
To evaluate the terminal half-life of XL092 alone and in combination with ICI
Time Frame
Up to 24 months
Title
Dose-Escalation Stage: Apparent Clearance (CL/F)
Description
To evaluate the CL/F of XL092 alone and in combination with ICI
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cytologically or histologically confirmed solid tumor that is inoperable locally advanced, metastatic, or recurrent. Dose-escalation (single-agent and combination therapy): Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology. Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standard of care chemotherapy regimens as prior therapy for metastatic CRC: Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF monoclonal antibody (bevacizumab) Anti-EGFR monoclonal antibody (cetuximab or panitumumab) BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1. Tumor tissue material: Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained. Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. Adequate organ and marrow function. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception. Female subjects of childbearing potential must not be pregnant at screening. Exclusion Criteria: Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, and H only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only). Receipt of any type of small molecule kinase inhibitor within 2 weeks before first dose of study treatment. Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before first dose of study treatment. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Uncontrolled, significant intercurrent or recent illness. Concomitant use of certain medications. Corrected QT interval calculated by the Fridericia formula (QTcF) > 450 ms for males and > 470 ms for females. Single ECGs are no longer permitted. Pregnant or lactating females. Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Additional Exclusion Criteria for XL092 + Atezolizumab Combination Therapy Cohorts ONLY: Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment. Additional Exclusion Criteria for XL092 + Avelumab Combination Therapy Cohorts ONLY: Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Exelixis Clinical Trials
Phone
1-888-EXELIXIS (888-393-5494)
Email
druginfo@exelixis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Backup or International
Phone
650-837-7400
Facility Information:
Facility Name
Exelixis Clinical Site #6
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #49
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #7
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #71
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #66
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #15
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #24
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #11
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Completed
Facility Name
Exelixis Clinical Site #41
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #36
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #62
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #44
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Exelixis Clinical Site #4
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #45
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #2
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #25
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Withdrawn
Facility Name
Exelixis Clinical Site #13
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #9
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #35
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #78
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #74
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #60
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #59
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #58
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #12
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #61
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #50
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #33
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #3
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #1
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #5
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #8
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #43
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #26
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #52
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #53
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #75
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #56
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #63
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #44
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #51
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #65
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #21
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #42
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #10
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #27
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #46
City
Clermont
State/Province
Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #37
City
Saint-Herblain Cedex
State/Province
Loire Atlantique
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #72
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #32
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #48
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #14
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #39
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #47
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #22
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #57
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #77
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #38
City
Nürtingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72622
Country
Germany
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #28
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #31
City
Münster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #64
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #67
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #69
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #54
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #73
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #79
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #76
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #23
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #20
City
Santiago De Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #18
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #19
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #29
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #30
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #34
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #55
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #17
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #16
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical #70
City
London
State/Province
England
ZIP/Postal Code
W1G6AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #40
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Exelixis Clinical Site #68
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR29HT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

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