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Closed (no longer recruiting)Last updated: 2 February 2024

STELLAR-001: This phase I study is evaluating how safe, tolerable and effective a new drug (XL092) is alone, or combined with immunotherapy (Atezolizumab or Avelumab) in people with inoperable, locally advanced or metastatic solid cancersA 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

Clinical summary

Summary

This is a dose escalation and cohort expansion study assessing XL092 alone, in combination with Atezolizumab, and in combination with Avelumab.

In Experimental Arm 1, XL092 Single-Agent Dose-Escalation, participants will accrue in cohorts of 3-6 in a standard 3+3 design, and will receive oral doses of XL092.

In Experimental Arm 2, XL092 Single-Agent Expansion Cohort, the maximum tolerated dose (MTD) or recommended dose of XL092 from the dose-escalation stage (Arm 1) 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 (mMRPC).

In Experimental Arm 3, XL092 + Atezolizumab Dose-Escalation, participants will accrue in cohorts of 2-6 in a "rolling 6" design. Participants will receive oral doses of XL092 in combination with Atezolizumab, administered as a 1200mg intravenous (IV) infusion once every 3 weeks.

In Experimental Arm 4, XL092 + Atezolizumab Expansion, the MTD or recommended dose of XL092 from the dose-escalation stage (Arm 3) 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). Atezolizumab will be administered the same as in Arm 3.

In Experimental Arm 5, XL092 + Avelumab Dose-Expansion, participants will accrue in cohorts of 2-6 in a "rolling 6" design. Participants will receive XL092 in combination with Avelumab, administered as an 800mg IV infusion once every 2 weeks. In Experimental Arm 6, XL092 + Avelumab Expansion, the MTD or recommended dose of XL092 from the dose-escalation stage (Arm 5) may be further explored in advanced urothelial carcinoma (UC). Avelumab will be administered the same as in Arm 5.

Conditions

This trial is treating patients with advanced solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

STELLAR-001

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Exelixis

Scientific Title

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

Eligibility

Inclusion

  • 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.

Exclusion

  • Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, and H only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only).
  • 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.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 450 ms for males and > 470 ms for females. Single ECGs are no longer permitted.
  • 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.
  • 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.
  • Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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