Clinical Trials /

A Study of XL092 in Subjects With Solid Tumors

NCT03845166

Description:

This is a Phase 1, open-label, dose-escalation study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect on biomarkers of XL092 administered orally to subjects with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of XL092 in Subjects With Solid Tumors
  • Official Title: A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: XL092-001
  • NCT ID: NCT03845166

Conditions

  • Neoplasm Malignant
  • Renal Cell Carcinoma
  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
XL092XL092 Dose-Escalation Cohorts

Purpose

This is a Phase 1, open-label, dose-escalation study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect on biomarkers of XL092 administered orally to subjects with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
XL092 Dose-Escalation CohortsExperimentalSubjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.
  • XL092
XL092 Dose Expansion CohortsExperimentalThe MTD or recommended dose from the dose-escalation stage will be further explored.
  • XL092

Eligibility Criteria

        Inclusion Criteria:

          -  Cytologically or histologically confirmed solid tumor that is inoperable locally
             advanced, metastatic, or recurrent.

          -  Dose-escalation: 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: Subjects with previously treated advanced RCC with clear cell or
             non-clear cell histology who have radiographically progressed following treatment with
             at least one prior systemic anticancer regimen for metastatic/advanced disease.

          -  Expansion Cohort B: Subjects with Stage IV NSCLC with non-squamous histology who have
             radiographically progressed following treatment with at least two prior systemic
             anticancer regimens for metastatic/advanced disease.

          -  Expansion Cohort C: Subjects with metastatic CRPC (adenocarcinoma of the prostate) who
             have radiographically progressed in soft tissue on or after enzalutamide and/or
             abiraterone acetate for metastatic disease. Neuroendocrine differentiation and other
             features permitted if adenocarcinoma is the primary histology.

          -  Expansion Cohorts: Subjects must have measurable disease.

          -  Tumor tissue material (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 medically
             accepted methods of contraception.

          -  Female subjects of childbearing potential must not be pregnant at screening.

        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

          -  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.

          -  Pregnant or lactating females
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:MTD/recommended dose for XL092
Time Frame:Up to 12 months
Safety Issue:
Description:To determine the maximum tolerated dose (MTD) and/or recommended dose

Secondary Outcome Measures

Measure:Preliminary activity of XL092
Time Frame:Up to 24 months
Safety Issue:
Description:To evaluate the preliminary antitumor activity of XL092 as assessed by objective responses

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Exelixis

Last Updated

August 4, 2019