Prostate Cancer Clinical Trial

Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors

Summary

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet) and nivolumab + ipilimumab (triplet) in subjects with advanced solid tumors.

In the Expansion Stage, the safety and efficacy of XL092 as combination therapy will be further evaluated in tumor-specific Expansion Cohorts, which will enroll subjects with genitourinary cancers.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.
Dose-Escalation Cohorts: 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 1 (ccRCC): Subjects with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.

Note: Prior non-VEGF targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.

Expansion Cohort 2 (ccRCC): Subjects with unresectable advanced or metastatic RCC with a clear cell component.

Must have radiographically progressed after a combination therapy consisting of a PD-1/PD-L1 targeting mAb with a VEGFR-TKI or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.
Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.

Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.

Must have progressed during or after one NHT given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.

Expansion Cohort 4 (UC, ICI-naive): Subjects with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).

Must have progressed during or after prior first-line platinum-based combination therapy, including subjects who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence < 12 months from the end of last therapy.
Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.

Expansion Cohort 5 (UC, ICI-experienced): Subjects with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).

Must have progressed during or after prior PD-1/PD-L1 targeting ICI therapy given as monotherapy, combination therapy, maintenance therapy or adjuvant therapy.
Must have received no more than 2 prior lines of systemic anticancer therapy for unresectable advanced or metastatic disease.

Expansion Cohort 6 (nccRCC): Subjects with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary RCC (any type), unclassified RCC, and translocation-associated. Among the eligible histologic subtypes, sarcomatoid features are allowed.

No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.
Expansion Cohort 7 (HCC): Subjects with inoperable locally advanced, recurrent, or metastatic HCC that is not amenable to curative treatment or locoregional therapy.
Expansion Cohort 8 (NSCLC): Subjects with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score [TPS] 1-49%) and without prior systemic anticancer therapy for metastatic disease.
Expansion Cohort 9 (NSCLC): Subjects with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.
Expansion Cohort 10 (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.
Expansion Cohort 11 (HNSCC): Subject with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.
For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.
For expansion cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
Karnofsky Performance Status (KPS) ≥ 70%.
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:

For all Dose-Escalation cohorts: Prior treatment with XL092. For all Expansion Cohorts: Prior treatment with XL092, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1/PD-L1, LAG-3 and CTLA-4 targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC).
For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC): Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy (including radiosurgery) or surgically removed and stable for at least 4 weeks before first dose of study treatment.
Concomitant anticoagulation with oral anticoagulants and platelet inhibitors.
Administration of a live, attenuated vaccine within 30 days prior to enrollment.
Uncontrolled, significant intercurrent or recent illness.
Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment.
Subjects with inadequately treated adrenal insufficiency.
Pregnant or lactating females.
Any other active malignancy within two years before first dose of study treatment, except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.
For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.
For Cohort 4 (UC, ICI-naïve): Subjects who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.
For Cohort 6 (nccRCC, 1L): Subjects with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.

For Cohort 7 (HCC):

Documented hepatic encephalopathy (HE) within 6 months before randomization (see Section 6.5.2 for a case definition of HE).
Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.
Subjects who have received any local anticancer therapy including surgery, PEI, RFA, MWA, transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to randomization.
Subjects with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma
For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and/or TAS-102.
For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.

For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, MSS, 2L+), and 11 (HNSCC):

Troponin T (TnT) or I (TnI) > 2 × institutional ULN.

Note: Additional Inclusion and Exclusion criteria may apply.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

1078

Study ID:

NCT05176483

Recruitment Status:

Recruiting

Sponsor:

Exelixis

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There are 119 Locations for this study

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Exelixis Clinical Site #67
Phoenix Arizona, 85054, United States
Exelixis Clinical Site #1
Tucson Arizona, 85711, United States
Exelixis Clinical Site #123
Palo Alto California, 94304, United States
Exelixis Clinical Site #59
Santa Barbara California, 93463, United States
Exelixis Clinical Site #87
Littleton Colorado, 80124, United States
Exelixis Clinical Site #62
New Haven Connecticut, 06510, United States
Exelixis Clinical Site #49
Newark Delaware, 19713, United States
Exelixis Clinical Site #48
Celebration Florida, 34747, United States
Exelixis Clinical Site #11
Gainesville Florida, 32610, United States
Exelixis Clinical Site #78
Jacksonville Florida, 32224, United States
Exelixis Clinical Site #47
Miami Florida, 33136, United States
Exelixis Clinical Site #61
Plantation Florida, 33322, United States
Exelixis Clinical Site #8
Tampa Florida, 33612, United States
Exelixis Clinical Site #26
Chicago Illinois, 60612, United States
Exelixis Clinical Site #4
Indianapolis Indiana, 46250, United States
Exelixis Clinical Site #122
Louisville Kentucky, 40202, United States
Exelixis Clinical Site #14
Baltimore Maryland, 21201, United States
Exelixis Clinical Site #7
Boston Massachusetts, 02215, United States
Exelixis Clinical Site #65
Detroit Michigan, 48201, United States
Exelixis Clinical Site #13
Detroit Michigan, 48202, United States
Exelixis Clinical Site #68
Rochester Minnesota, 55905, United States
Exelixis Clinical Site #2
Omaha Nebraska, 68130, United States
Exelixis Clinical Site #5
Omaha Nebraska, 68130, United States
Exelixis Clinical Site #55
Las Vegas Nevada, 89052, United States
Exelixis Clinical Site #88
East Brunswick New Jersey, 08816, United States
Exelixis Clinical Site #105
Hackensack New Jersey, 07601, United States
Exelixis Clinical Site #60
New York New York, 10032, United States
Exelixis Clinical Site #6
New York New York, 10065, United States
Exelixis Clinical Site #76
Syracuse New York, 13210, United States
Exelixis Clinical Site #12
Durham North Carolina, 27710, United States
Exelixis Clinical Site #10
Cleveland Ohio, 44106, United States
Exelixis Clinical Site #51
Portland Oregon, 97239, United States
Exelixis Clinical Site #104
Hershey Pennsylvania, 17033, United States
Exelixis Clinical Site #98
Philadelphia Pennsylvania, 19104, United States
Exelixis Clinical Site #32
Pittsburgh Pennsylvania, 15212, United States
Exelixis Clinical Site #24
Pittsburgh Pennsylvania, 15232, United States
Exelixis Clinical Site #9
Myrtle Beach South Carolina, 29572, United States
Exelixis Clinical Site #3
Nashville Tennessee, 37203, United States
Exelixis Clinical Site #46
Austin Texas, 78705, United States
Exelixis Clinical Site #111
Dallas Texas, 75246, United States
Exelixis Clinical Site #89
Dallas Texas, 75246, United States
Exelixis Clinical Site #73
Irving Texas, 75063, United States
Exelixis Clinical Site #50
Plano Texas, 75075, United States
Exelixis Clinical Site #70
Tyler Texas, 75601, United States
Exelixis Clinical Site #66
Charlottesville Virginia, 22903, United States
Exelixis Clinical Site #33
Milwaukee Wisconsin, 53226, United States
Exelixis Clinical Site #116
Albury , 2640, Australia
Exelixis Clinical Site #35
Birtinya , 4575, Australia
Exelixis Clinical Site #16
Brisbane , 4102, Australia
Exelixis Clinical Site #42
Saint Leonards , 2065, Australia
Exelixis Clinical Site #36
Sydney , 2109, Australia
Exelixis Clinical Site #94
Graz , 8036, Austria
Exelixis Clinical Site #31
Salzburg , 5020, Austria
Exelixis Clinical Site #106
Wein , 1090, Austria
Exelixis Clinical Site #29
Wien , 1020, Austria
Exelixis Clinical Site #39
Anderlecht , 1070, Belgium
Exelixis Clinical Site #37
Kortrijk , 8500, Belgium
Exelixis Clinical Site #85
Besançon , 25030, France
Exelixis Clinical Site #96
Bordeaux , 33000, France
Exelixis Clinical Site #79
Caen , 14076, France
Exelixis Clinical Site #118
Clermont-Ferrand , 63011, France
Exelixis Clinical Site #109
Lyon , 69008, France
Exelixis Clinical Site #92
Marseille , 13273, France
Exelixis Clinical Site #64
Nice , 06189, France
Exelixis Clinical Site #83
Paris , 75010, France
Exelixis Clinical Site #91
Paris , 75015, France
Exelixis Clinical Site #80
Rennes , 35042, France
Exelixis Clinical Site #63
Saint-Herblain , 44805, France
Exelixis Clinical Site #75
Strasbourg , 67200, France
Exelixis Clinical Site #84
Vandœuvre-lès-Nancy , 54519, France
Exelixis Clinical Site #115
Villejuif , 94805, France
Exelixis Clinical Site #103
Essen , 45147, Germany
Exelixis Clinical Site #113
Hamburg , 22763, Germany
Exelixis Clinical Site #108
Heidelberg , 69120, Germany
Exelixis Clinical Site #82
Herne , 44625, Germany
Exelixis Clinical Site #93
Jena , 07747, Germany
Exelixis Clinical Site #112
München , 81737, Germany
Exelixis Clinical Site #102
Nürtingen , 72622, Germany
Exelixis Clinical Site #107
Trier , 54292, Germany
Exelixis Clinical Site #95
Tübingen , 72076, Germany
Exelixis Clinical Site #86
Be'er Sheva , 84101, Israel
Exelixis Clinical Site #72
Haifa , 31096, Israel
Exelixis Clinical Site #52
Jerusalem , 91120, Israel
Exelixis Clinical Site #71
Petah Tikva , 49414, Israel
Exelixis Clinical Site #69
Tel Aviv , 64239, Israel
Exelixis Clinical Site #38
Zerifin , 70300, Israel
Exelixis Clinical Site #121
Ancona , 60020, Italy
Exelixis Clinical Site #117
Bologna , 40138, Italy
Exelixis Clinical Site #90
Firenze , 50134, Italy
Exelixis Clinical Site #101
Milano , 20132, Italy
Exelixis Clinical Site #81
Milano , 20141, Italy
Exelixis Clinical Site #40
Napoli , 80131, Italy
Exelixis Clinical Site #74
Ravenna , 48121, Italy
Exelixis Clinical Site #30
Grafton , 1023, New Zealand
Exelixis Clinical Site #45
Hamilton , 3204, New Zealand
Exelixis Clinical Site #20
Bydgoszcz , 85-79, Poland
Exelixis Clinical Site #28
Gdańsk , 80-21, Poland
Exelixis Clinical Site #34
Otwock , 05-40, Poland
Exelixis Clinical Site #54
Poznań , 60-56, Poland
Exelixis Clinical Site #114
Wrocław , 53-41, Poland
Exelixis Clinical Site #41
Badajoz , 06080, Spain
Exelixis Clinical Site #53
Barcelona , 08035, Spain
Exelixis Clinical Site #15
Barcelona , 08036, Spain
Exelixis Clinical Site #27
Barcelona , 08041, Spain
Exelixis Clinical Site #120
L'Hospitalet De Llobregat , 08908, Spain
Exelixis Clinical Site #57
Madrid , 28033, Spain
Exelixis Clinical Site #43
Madrid , 28034, Spain
Exelixis Clinical Site #58
Madrid , 28040, Spain
Exelixis Clinical Site #77
Madrid , 28040, Spain
Exelixis Clinical Site #19
Madrid , 28041, Spain
Exelixis Clinical Site #100
Madrid , 28046, Spain
Exelixis Clinical Site #18
Pamplona , 31008, Spain
Exelixis Clinical Site #119
Santander , 39008, Spain
Exelixis Clinical Site #23
Seville , 41013, Spain
Exelixis Clinical Site #56
Valencia , 46010, Spain
Exelixis Clinical Site #25
Valencia , 46026, Spain
Exelixis Clinical Site #21
Chur , 7000, Switzerland
Exelixis Clinical Site #22
St. Gallen , 9007, Switzerland
Exelixis Clinical Site #44
Winterthur , 8401, Switzerland
Exelixis Clinical Site #110
Cambridge , CB2 0, United Kingdom
Exelixis Clinical Site #99
London , W6 8R, United Kingdom
Exelixis Clinical Site #97
Middlesex , HA6 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

1078

Study ID:

NCT05176483

Recruitment Status:

Recruiting

Sponsor:


Exelixis

How clear is this clinincal trial information?

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