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 (STELLAR-001)

  • STATUS
    Recruiting
  • End date
    Nov 28, 2024
  • participants needed
    1195
  • sponsor
    Exelixis
Updated on 28 October 2022
cancer
monoclonal antibodies
measurable disease
carcinoma
breast cancer
vegf
growth factor
treatment regimen
BRAF
KRAS
NRAS
metastasis
oxaliplatin
metastatic adenocarcinoma
adenocarcinoma of the colon
carboplatin
avelumab
panitumumab
fluoropyrimidine
gemcitabine
epidermal growth factor receptor
EGFR
irinotecan
bevacizumab
cetuximab
programmed cell death 1 ligand 1
primary cancer
cancer chemotherapy
adenocarcinoma
solid tumour
solid tumor
erbb2
epidermal growth factor
solid neoplasm
transitional cell carcinoma
atezolizumab
metastatic transitional cell carcinoma
stage iv nsclc
stage iv non-small cell lung cancer

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.

Details
Condition Neoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Castration-resistant Prostate Cancer, Urothelial Carcinoma, Colorectal Cancer
Treatment Avelumab, Atezolizumab, XL092
Clinical Study IdentifierNCT03845166
SponsorExelixis
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
Tumor tissue material
Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF monoclonal antibody (bevacizumab)
Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained
Anti-EGFR monoclonal antibody (cetuximab or panitumumab)
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
BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations
Expansion Cohort I (UC, Maintenance Therapy): Subjects with histologically confirmed
Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1, with exception of Cohort I (UC, Maintenance Therapy)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
unresectable, locally advanced or metastatic transitional cell carcinoma of
the urothelium (including the renal pelvis, ureter, urinary bladder, or
Adequate organ and marrow function
urethra) who received first-line chemotherapy of gemcitabine + cisplatin
and/or gemcitabine + carboplatin
Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs)
Female subjects of childbearing potential must not be pregnant at screening
including immune-related adverse events (irAEs), related to any prior
treatments, unless AE(s) are clinically nonsignificant and/or stable on
supportive therapy
Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception

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
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
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)
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
Corrected QT interval calculated by the Fridericia formula (QTcF) > 450 ms for males and > 470 ms for females. Single ECGs are no longer permitted
Administration of a live, attenuated vaccine within 30 days before first dose of study treatment
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