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Neoplasm MalignantPhase 1STELLAR-001NCT03845166

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

A Phase 1 study testing XL092, Atezolizumab and Avelumab in people with Neoplasm Malignant and Renal Cell Carcinoma, run by Exelixis at 86 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
XL092, Atezolizumab and Avelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
86 sitesin 10 countries
Study dates
20 Mar 2019to 31 May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 18Show fewer
  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

86 sites in 10 countries.

86 sites in 10 countries

United States40 sites

  • Exelixis Clinical Site #45

    Ann Arbor, Michigan, 48109

  • Exelixis Clinical Site #11

    Atlanta, Georgia, 30322

  • Exelixis Clinical Site #80

    Atlanta, Georgia, 30342

  • Exelixis Clinical Site #44

    Baltimore, Maryland, 21201

  • Exelixis Clinical Site #4

    Boston, Massachusetts, 02215

  • Exelixis Clinical Site #61

    Charleston, South Carolina, 29425

  • Exelixis Clinical Site #8

    Charlottesville, Virginia, 22903

  • Exelixis Clinical #74

    Cincinnati, Ohio, 45219

  • Exelixis Clinical Site #60

    Cleveland, Ohio, 44106

  • Exelixis Clinical Site #6

    Duarte, California, 91010

  • Exelixis Clinical Site #9

    East Brunswick, New Jersey, 08816

  • Exelixis Clinical Site #33

    Germantown, Tennessee, 38138

  • Exelixis Clinical Site #2

    Grand Rapids, Michigan, 49546

  • Exelixis Clinical Site #59

    Hershey, Pennsylvania, 17033

  • Exelixis Clinical Site #3

    Houston, Texas, 77030

  • Exelixis Clinical Site #41

    Iowa City, Iowa, 52242

  • Exelixis Clinical Site #49

    La Jolla, California, 92093

  • Exelixis Clinical Site #15

    Lake Mary, Florida, 32746

  • Exelixis Clinical Site #7

    Los Angeles, California, 90025

  • Exelixis Clinical Site #84

    Los Angeles, California, 90095

  • Exelixis Clinical Site #24

    Miami, Florida, 33136

  • Exelixis Clinical Site #50

    Myrtle Beach, South Carolina, 29572

  • Exelixis Clinical Site #87

    Nashville, Tennessee, 37203

  • Exelixis Clinical Site #83

    New Brunswick, New Jersey, 08903

  • Exelixis Clinical Site #86

    New York, New York, 10021

  • Exelixis Clinical Site #35

    New York, New York, 10029

  • Exelixis Clinical #78

    New York, New York, 10065

  • Exelixis Clinical Site #13

    Omaha, Nebraska, 68130

  • Exelixis Clinical Site #58

    Philadelphia, Pennsylvania, 19107

  • Exelixis Clinical Site #12

    Pittsburgh, Pennsylvania, 15232

  • Exelixis Clinical Site #43

    Richmond, Virginia, 23219

  • Exelixis Clinical Site #25

    Saint Paul, Minnesota, 55101

  • Exelixis Clinical Site #5

    Salt Lake City, Utah, 84112

  • Exelixis Clinical Site #1

    San Antonio, Texas, 78229

  • Exelixis Clinical Site #66

    San Francisco, California, 94158

  • Exelixis Clinical Site #62

    Scarborough, Maine, 04074

  • Exelixis Clinical Site #26

    Spokane, Washington, 99208

  • Exelixis Clinical Site #71

    Stanford, California, 94305

  • Exelixis Clinical Site #85

    The Bronx, New York, 10461

  • Exelixis Clinical Site #36

    Westwood, Kansas, 66205

Other trials in United States

France11 sites

  • Exelixis Clinical #72

    Bordeaux, 33000

  • Exelixis Clinical Site #32

    Caen, 14076

  • Exelixis Clinical Site #46

    Clermont, Ferrand, 63011

  • Exelixis Clinical Site #48

    Marseille, 13009

  • Exelixis Clinical Site #14

    Paris, 75015

  • Exelixis Clinical Site #39

    Pierre-Bénite, 69495

  • Exelixis Clinical Site #47

    Poitiers, 86021

  • Exelixis Clinical Site #37

    Saint-Herblain, Loire Atlantique, 44805

  • Exelixis Clinical Site #22

    Suresnes, 92150

  • Exelixis Clinical Site #57

    Toulouse, 31059

  • Exelixis Clinical #77

    Villejuif, 94805

Other trials in France

Spain11 sites

  • Exelixis Clinical Site #18

    Barcelona, 08003

  • Exelixis Clinical Site #19

    Barcelona, 08023

  • Exelixis Clinical Site #29

    Barcelona, 08035

  • Exelixis Clinical Site #30

    Barcelona, 08036

  • Exelixis Clinical Site #81

    Madrid, 28007

  • Exelixis Clinical Site #34

    Madrid, 28040

  • Exelixis Clinical Site #55

    Madrid, 28041

  • Exelixis Clinical Site #17

    Madrid, 28046

  • Exelixis Clinical Site #23

    Sabadell, Barcelona, 08208

  • Exelixis Clinical Site #20

    Santiago de Compostela, La Coruna, 15706

  • Exelixis Clinical Site #16

    Seville, 41013

Other trials in Spain

Australia5 sites

  • Exelixis Clinical Site #52

    Darlinghurst, New South Wales, 2010

  • Exelixis Clinical Site #63

    Heidelberg, Victoria, 3084

  • Exelixis Clinical Site #56

    Kurralta Park, South Australia, 5037

  • Exelixis Clinical Site #53

    Liverpool, New South Wales, 2170

  • Exelixis Clinical #75

    South Brisbane, Queensland, 4101

Other trials in Australia

Czechia4 sites

  • Exelixis Clinical Site #21

    Brno, 656 91

  • Exelixis Clinical Site #42

    Hradec Králové, 500 05

  • Exelixis Clinical Site #10

    Olomouc, 779 00

  • Exelixis Clinical Site #27

    Prague, 140 59

Other trials in Czechia

Italy4 sites

  • Exelixis Clinical Site #67

    Milan, MI, 20132

  • Exelixis Clinical Site #54

    Milan, 20141

  • Exelixis Clinical #73

    Naples, 80131

  • Exelixis Clinical Site #69

    Pavia, PV, 27100

Other trials in Italy

Belgium3 sites

  • Exelixis Clinical Site #51

    Brussels, 1200

  • Exelixis Clinical Site #44

    Edegem, Antwerpen, 2650

  • Exelixis Clinical Site #65

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

Germany3 sites

  • Exelixis Clinical Site #64

    Hamburg, 20249

  • Exelixis Clinical Site #31

    Münster, North Rhine-Westphalia, 48149

  • Exelixis Clinical Site #38

    Nürtingen, Baden-Wurttemberg, 72622

Other trials in Germany

United Kingdom3 sites

  • Exelixis Clinical #70

    London, England, W1G6AD

  • Exelixis Clinical Site #68

    Preston, Lancashire, PR29HT

  • Exelixis Clinical Site #40

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Netherlands2 sites

  • Exelixis Clinical Site #79

    Amsterdam, North Holland, 1066 CX

  • Exelixis Clinical #76

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

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

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.

Being tested
XL092, Atezolizumab, Avelumab
Medical subject headings
Neoplasms, Carcinoma, Renal Cell, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XL092Drug

    oral doses of XL092

  • AtezolizumabDrug

    Also called Tecentriq®

    Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)

  • AvelumabDrug

    Also called Bavencio®

    Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)

Study groups in NCT03845166
Study groupRoleWhat they receive
XL092 Single-Agent Dose-Escalation CohortsExperimentalSubjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.
Receives: Drug: XL092
XL092 Single-Agent Expansion CohortsExperimentalThe 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).
Receives: Drug: XL092
XL092 + Atezolizumab Dose-Escalation CohortsExperimentalSubjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.
Receives: Drug: XL092; Drug: Atezolizumab
XL092 + Atezolizumab Expansion CohortsExperimentalThe 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).
Receives: Drug: XL092; Drug: Atezolizumab
XL092 + Avelumab Dose-Escalation CohortsExperimentalSubjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.
Receives: Drug: XL092; Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 24 months

  2. 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

    Measured: Up to 24 months

  3. 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 (except for the CRC expansion cohort H)

    Measured: Up to 24 months

  4. 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)

    Measured: Up to 24 months

Secondary outcomes (6)

  1. 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)

    Measured: Up to 36 months

  2. Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax)

    To evaluate the Tmax of XL092 alone and in combination with ICI

    Measured: Up to 24 months

  3. Dose-Escalation Stage: Maximum Plasma Concentration (Cmax)

    To evaluate the Cmax of XL092 alone and in combination with ICI

    Measured: Up to 24 months

  4. 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

    Measured: Up to 24 months

  5. Dose-Escalation Stage: Terminal Half-Life

    To evaluate the terminal half-life of XL092 alone and in combination with ICI

    Measured: Up to 24 months

  6. Dose-Escalation Stage: Apparent Clearance (CL/F)

    To evaluate the CL/F of XL092 alone and in combination with ICI

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2019
  2. Study start20 Mar 2019
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
single-agent and combination therapy dose-escalation followed by cohort-expansion
Masking
None (open label)
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03845166
Sponsor's protocol ID
XL092-001
Other IDs
2020-003569-21
Acronym
STELLAR-001
Status last verified
Nov 2024
First submitted
15 Feb 2019
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL092, Atezolizumab and Avelumab in people with Neoplasm Malignant and Renal Cell Carcinoma, run by Exelixis at 86 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, France, Spain, Australia, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Escalation Stage: MTD/recommended dose for XL092 (time frame: Up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03845166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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