A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
NCT ID: NCT03845166
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
325 participants
INTERVENTIONAL
2019-03-20
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
NCT04250155
A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors
NCT02410512
A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors
NCT06630247
Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
NCT03170960
A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid Tumors
NCT02715531
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
XL092 Single-Agent Dose-Escalation Cohorts
Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.
XL092
oral doses of XL092
XL092 Single-Agent Expansion Cohorts
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).
XL092
oral doses of XL092
XL092 + Atezolizumab Dose-Escalation Cohorts
Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.
XL092
oral doses of XL092
Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
XL092 + Atezolizumab Expansion Cohorts
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).
XL092
oral doses of XL092
Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
XL092 + Avelumab Dose-Escalation Cohorts
Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.
XL092
oral doses of XL092
Avelumab
Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
XL092
oral doses of XL092
Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
Avelumab
Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
* 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.
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Exelixis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Exelixis Clinical Site #6
Duarte, California, United States
Exelixis Clinical Site #49
La Jolla, California, United States
Exelixis Clinical Site #7
Los Angeles, California, United States
Exelixis Clinical Site #84
Los Angeles, California, United States
Exelixis Clinical Site #66
San Francisco, California, United States
Exelixis Clinical Site #71
Stanford, California, United States
Exelixis Clinical Site #15
Lake Mary, Florida, United States
Exelixis Clinical Site #24
Miami, Florida, United States
Exelixis Clinical Site #11
Atlanta, Georgia, United States
Exelixis Clinical Site #80
Atlanta, Georgia, United States
Exelixis Clinical Site #41
Iowa City, Iowa, United States
Exelixis Clinical Site #36
Westwood, Kansas, United States
Exelixis Clinical Site #62
Scarborough, Maine, United States
Exelixis Clinical Site #44
Baltimore, Maryland, United States
Exelixis Clinical Site #4
Boston, Massachusetts, United States
Exelixis Clinical Site #45
Ann Arbor, Michigan, United States
Exelixis Clinical Site #2
Grand Rapids, Michigan, United States
Exelixis Clinical Site #25
Saint Paul, Minnesota, United States
Exelixis Clinical Site #13
Omaha, Nebraska, United States
Exelixis Clinical Site #9
East Brunswick, New Jersey, United States
Exelixis Clinical Site #83
New Brunswick, New Jersey, United States
Exelixis Clinical Site #86
New York, New York, United States
Exelixis Clinical Site #35
New York, New York, United States
Exelixis Clinical #78
New York, New York, United States
Exelixis Clinical Site #85
The Bronx, New York, United States
Exelixis Clinical #74
Cincinnati, Ohio, United States
Exelixis Clinical Site #60
Cleveland, Ohio, United States
Exelixis Clinical Site #59
Hershey, Pennsylvania, United States
Exelixis Clinical Site #58
Philadelphia, Pennsylvania, United States
Exelixis Clinical Site #12
Pittsburgh, Pennsylvania, United States
Exelixis Clinical Site #61
Charleston, South Carolina, United States
Exelixis Clinical Site #50
Myrtle Beach, South Carolina, United States
Exelixis Clinical Site #33
Germantown, Tennessee, United States
Exelixis Clinical Site #87
Nashville, Tennessee, United States
Exelixis Clinical Site #3
Houston, Texas, United States
Exelixis Clinical Site #1
San Antonio, Texas, United States
Exelixis Clinical Site #5
Salt Lake City, Utah, United States
Exelixis Clinical Site #8
Charlottesville, Virginia, United States
Exelixis Clinical Site #43
Richmond, Virginia, United States
Exelixis Clinical Site #26
Spokane, Washington, United States
Exelixis Clinical Site #52
Darlinghurst, New South Wales, Australia
Exelixis Clinical Site #53
Liverpool, New South Wales, Australia
Exelixis Clinical #75
South Brisbane, Queensland, Australia
Exelixis Clinical Site #56
Kurralta Park, South Australia, Australia
Exelixis Clinical Site #63
Heidelberg, Victoria, Australia
Exelixis Clinical Site #44
Edegem, Antwerpen, Belgium
Exelixis Clinical Site #65
Ghent, Oost-Vlaanderen, Belgium
Exelixis Clinical Site #51
Brussels, , Belgium
Exelixis Clinical Site #21
Brno, , Czechia
Exelixis Clinical Site #42
Hradec Králové, , Czechia
Exelixis Clinical Site #10
Olomouc, , Czechia
Exelixis Clinical Site #27
Prague, , Czechia
Exelixis Clinical Site #46
Clermont, Ferrand, France
Exelixis Clinical Site #37
Saint-Herblain, Loire Atlantique, France
Exelixis Clinical #72
Bordeaux, , France
Exelixis Clinical Site #32
Caen, , France
Exelixis Clinical Site #48
Marseille, , France
Exelixis Clinical Site #14
Paris, , France
Exelixis Clinical Site #39
Pierre-Bénite, , France
Exelixis Clinical Site #47
Poitiers, , France
Exelixis Clinical Site #22
Suresnes, , France
Exelixis Clinical Site #57
Toulouse, , France
Exelixis Clinical #77
Villejuif, , France
Exelixis Clinical Site #38
Nürtingen, Baden-Wurttemberg, Germany
Exelixis Clinical Site #31
Münster, North Rhine-Westphalia, Germany
Exelixis Clinical Site #64
Hamburg, , Germany
Exelixis Clinical Site #67
Milan, MI, Italy
Exelixis Clinical Site #69
Pavia, PV, Italy
Exelixis Clinical Site #54
Milan, , Italy
Exelixis Clinical #73
Napoli, , Italy
Exelixis Clinical Site #79
Amsterdam, North Holland, Netherlands
Exelixis Clinical #76
Rotterdam, South Holland, Netherlands
Exelixis Clinical Site #23
Sabadell, Barcelona, Spain
Exelixis Clinical Site #20
Santiago de Compostela, La Coruna, Spain
Exelixis Clinical Site #18
Barcelona, , Spain
Exelixis Clinical Site #19
Barcelona, , Spain
Exelixis Clinical Site #29
Barcelona, , Spain
Exelixis Clinical Site #30
Barcelona, , Spain
Exelixis Clinical Site #81
Madrid, , Spain
Exelixis Clinical Site #34
Madrid, , Spain
Exelixis Clinical Site #55
Madrid, , Spain
Exelixis Clinical Site #17
Madrid, , Spain
Exelixis Clinical Site #16
Seville, , Spain
Exelixis Clinical #70
London, England, United Kingdom
Exelixis Clinical Site #40
Sutton, England, United Kingdom
Exelixis Clinical Site #68
Preston, Lancashire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-003569-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
XL092-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.