A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

Conditions

• Colorectal Cancer
• Hormone Receptor Positive Breast Carcinoma
• Metastatic Castration-resistant Prostate Cancer
• Neoplasm Malignant
• Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• XL092 — DRUG
  oral doses of XL092
• Atezolizumab — DRUG
  Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
• Avelumab — DRUG
  Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)

Study Details

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.

Key Dates

Start date

Mar 20, 2019

Status verified

Nov 2024

Primary completion

Aug 31, 2026

Completion

May 31, 2027

Study Design

Enrollment

325 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: XL092 Single-Agent Dose-Escalation Cohorts
  Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.
• Experimental: XL092 Single-Agent Expansion Cohorts
  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).
• Experimental: XL092 + Atezolizumab Dose-Escalation Cohorts
  Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.
• Experimental: XL092 + Atezolizumab Expansion Cohorts
  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).
• Experimental: XL092 + Avelumab Dose-Escalation Cohorts
  Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.

Primary Outcome Measure

Dose-Escalation Stage: MTD/recommended dose for XL092 [ Time Frame: Up to 24 months ]

Locations (40)

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