Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XL092 · 5 trials · 9 indications
Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the BIRC or death from any cause
Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BIRC that is confirmed at a follow-up assessment ≥ 28 days later
ORR is defined as the proportion of patients with partial response and complete response per RECIST version 1.1 criteria at any time prior to 6 months
To evaluate the disease control rate at 16 weeks in metastatic castrate-resistant prostate cancer (mCRPC) patients treated with XL092 after progression on 177Lu-PSMA-617
To determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for further evaluation of XL092 when administered alone and in combination with immune checkpoint inhibitors (ICIs) to subjects with advanced solid tumors
To evaluate preliminary efficacy of XL092 when administered alone and in combination with ICIs by estimating ORR as assessed by the Investigator per RECIST 1.1
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with ICIs for specific cohorts by estimating the percentage of subjects with PFS at 6 months (PFS rate) per RECIST 1.1 as assessed by the Investigator (except for the CRC expansion cohort H)
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with atezolizumab for subjects with RAS wild-type CRC (Cohort H Treatment Arms H-A and H-B) by estimating overall survival (OS)
| Arm | Type | Description |
|---|---|---|
| XL092 + Nivolumab | EXPERIMENTAL | Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab |
| Sunitinib Malate | ACTIVE_COMPARATOR | Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib |
| XL092 + Atezolizumab | EXPERIMENTAL | Participants with mCRC will receive XL092 + atezolizumab. |
| Regorafenib | ACTIVE_COMPARATOR | Participants with mCRC will receive active comparator of regorafenib. |
| Arm A: XL092 | EXPERIMENTAL | Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of XL092 60 mg orally alone and will be taken once daily continuously (Day 1-Day 28). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate. |
| Arm B: XL092 and Nivolumab | EXPERIMENTAL | Study treatment will be given in 28-day (4 week) cycles. Arm B treatment will consist of XL092 60 mg plus nivolumab 480 mg intravenously. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate. |
| Treatment: All Patients | EXPERIMENTAL | XL092 is an oral tablet that will be taken once per day on a 28 day cycle. Participants will take a 60mg dose. Dose reductions to 40mg or 20mg may apply for in cases of dose interruption due to treatment-related toxicity. |
| XL092 Single-Agent Dose-Escalation Cohorts | EXPERIMENTAL | Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design. |
| XL092 Single-Agent Expansion Cohorts | EXPERIMENTAL | 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 + Atezolizumab Dose-Escalation Cohorts | EXPERIMENTAL | Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design. |
| XL092 + Atezolizumab Expansion Cohorts | EXPERIMENTAL | 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 + Avelumab Dose-Escalation Cohorts | EXPERIMENTAL | Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design. |
| Name | Type | Description |
|---|---|---|
| XL092 | DRUG | Specified doses on specified days |
| Nivolumab | DRUG | Specified doses on specified days |
| Sunitinib Malate | DRUG | Specified doses on specified days |
| Atezolizumab | DRUG | Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w). |
| Regorafenib | DRUG | Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle. |
| Avelumab | DRUG | Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w) |
Inclusion Criteria: * Histologically confirmed nccRCC that is unresectable, advanced or metastatic. Histologic subtypes including papillary, unclassified, and translocation-associated are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed. * Measurable disease accordi...
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XL092 is an investigational small molecule being studied in oncology. It is being evaluated for advanced renal cell carcinoma, colorectal cancer, non-clear cell renal cell carcinoma, metastatic castration-resistant prostate cancer, and other solid tumors. It is currently in clinical development and is not approved by the FDA.
XL092 is being developed by Exelixis, Inc., a biopharmaceutical company traded on NASDAQ under the ticker EXEL. The company is conducting multiple clinical trials to evaluate the drug as a single agent and in combination with other therapies for various cancer indications.
XL092 is in Phase 2 clinical development. It is being studied in a Phase 2 trial for metastatic castration-resistant prostate cancer. Additionally, it is part of earlier-stage trials, including a Phase 1 study in solid tumors and Phase 3 trials for colorectal cancer and non-clear cell renal cell carcinoma.
XL092 is being studied in several trials, including NCT03845166, a Phase 1 study in solid tumors; NCT05425940, a Phase 3 trial in metastatic colorectal cancer; NCT05678673, a Phase 3 trial in non-clear cell renal cell carcinoma; and NCT06568562, a Phase 2 trial in metastatic castration-resistant prostate cancer.
Yes, XL092 is being evaluated in combination with other therapies. A Phase 3 trial (NCT05425940) is studying XL092 plus atezolizumab versus regorafenib in metastatic colorectal cancer. Another Phase 3 trial (NCT05678673) is testing XL092 plus nivolumab versus sunitinib in non-clear cell renal cell carcinoma.