A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors (STELLAR-002)

  • STATUS
    Recruiting
  • End date
    May 17, 2026
  • participants needed
    622
  • sponsor
    Exelixis
Updated on 17 October 2022
cancer
monoclonal antibodies
systemic therapy
measurable disease
carcinoma
vegf
karnofsky performance status
metastatic adenocarcinoma
programmed cell death 1 ligand 1
nivolumab
ipilimumab
transitional cell carcinoma
metastatic transitional cell carcinoma
metastatic renal cell carcinoma

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.

Details
Condition Renal Cell Carcinoma, Metastatic Castration-resistant Prostate Cancer, Urothelial Carcinoma, Solid Tumor
Treatment Ipilimumab, Nivolumab, XL092, bempegaldesleukin
Clinical Study IdentifierNCT05176483
SponsorExelixis
Last Modified on17 October 2022

Eligibility

Yes No Not Sure

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
Expansion Cohort 4 (UC, ICI-naive): Subjects with histologically confirmed
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
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
Expansion Cohort 5 (UC, ICI-experienced): Subjects with histologically confirmed
unresectable, locally advanced or metastatic transitional cell carcinoma of
Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease
the urothelium (including the renal pelvis, ureter, urinary bladder, or
urethra)
Expansion Cohort 6 (nccRCC): Subjects with unresectable advanced or metastatic nccRCC
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
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 Cohorts 1, 2, 4, 5, 6: Measurable disease per RECIST 1.1 as determined by
of the following subtypes: Papillary RCC (any type), unclassified RCC, and
the Investigator
translocation-associated. Among the eligible histologic subtypes, sarcomatoid
features are allowed
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 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
Prior external radiation therapy within 2 weeks and prior radium-223 therapy within 6 weeks before first dose of study treatment
For all Dose-Escalation cohorts: Prior treatment with XL092. For all Expansion Cohorts: Prior treatment with XL092, nivolumab, or ipilimumab with the following exceptions: Prior PD-1/PD-L1 and CTLA-4 targeting therapy for locally advanced or metastatic disease is allowed for Cohorts 2 (ccRCC 2L) and 5 (UC [ICI-experienced])
For all Dose-Escalation Cohorts and Expansion Cohorts 2 (ccRCC), 3 (mCRPC), 4 and 5 (UC): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment
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
For all Dose-Escalation Cohorts and Expansion Cohorts 2 (ccRCC), 3 (mCRPC), 4 and 5 (UC): Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment
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
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
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
Note: Additional Inclusion and Exclusion criteria may apply
Administration of a live, attenuated vaccine within 30 days prior to enrollment
Subjects with inadequately treated adrenal insufficiency
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