A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
18 Years and older, Male and Female
XL092-001 (primary)
NCI-2019-03738
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.
Eligibility
- 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:
- 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.
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