A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: XB002-101
  • Secondary ID: N/A
  • NTC ID: NCT04925284
  • Sponsor: Exelixis

BRIEF SUMMARY

This is a Phase 1, non-randomized, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w as a monotherapy to subjects with advanced solid tumors.

  • Overall Status
    Recruiting
  • Start Date
    June 7, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose-Escalation Stage: MTD/recommended dose for XB002

Primary Outcome 1 - Timeframe: 18 months

Primary Outcome 2 - Measure: Cohort-Expansion Stage: Objective Response Rate (ORR)

Primary Outcome 2 - Timeframe: 12 months

CONDITION

  • Non Small Cell Lung Cancer
  • Urothelial Cancer
  • Epithelial Ovarian Cancer
  • Cervical Cancer
  • SCCHN
  • Pancreatic Cancer

ELIGIBILITY

Inclusion Criteria:
Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.

- Dose-Escalation Stage Cohort A and Cohort-Expansion Stage (Cohorts B - G): The subject has received standard life-prolonging therapies unless they do not exist, or available therapies are intolerable or no longer effective.

- Cohort-Expansion Stage Cohort B (Non-small Cell Lung Cancer): Subjects with Stage IV NSCLC who have documented radiographic disease progression during or following their last systemic anticancer therapy.

- Cohort-Expansion Stage Cohort C (Urothelial Cancer): Subjects with transitional cell histology (including renal pelvis, ureter, urinary bladder, urethra) who have documented radiographic disease progression during or following their last systemic anticancer therapy.

- Cohort-Expansion Stage Cohort D (Epithelial Ovarian Cancer): Subjects with epithelial ovarian cancer, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) who have platinum-resistant disease following treatment with platinum-containing chemotherapy. Note: Ovarian borderline epithelial tumors (low malignant potential) are not eligible.

- Cohort-Expansion Stage Cohort E (Cervical Cancer): Subjects with carcinoma of the uterine cervix who have documented radiographic disease progression during or following their last systemic anticancer therapy.

- Cohort F (SCCHN): Subjects with head and neck cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. Allowed primary tumor locations are oral cavity, oropharynx, hypopharynx, glottic larynx. Note: Excluded are subjects with primary tumor site of the nasopharynx.

- Cohort G (Pancreatic Cancer): Subjects with pancreatic cancer (adenocarcinoma histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy.

- Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1 as determined by the Investigator.

- Tumor tissue material collected approximately 2 years prior to consent. If archival tumor tissue is not available, a fresh tumor biopsy may be collected from subjects enrolled in the Dose-Escalation Stage and must be collected from subjects in the Cohort-Expansion Stage, at least 7 days (and up to 60 days) prior to first dose.

- Recovery to baseline or ≤ Grade 1 severity (Common Terminology Criteria for Adverse Events version 5 [CTCAE v5]) from AEs.

- 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 prior therapies as defined in study protocol

- 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.

- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG).

- 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-888-EXELIXIS (888-393-5494), 650-837-7400

Email: druginfo@exelixis.com

LOCATION

Facility Status Contact
Facility: Site 3
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: Site 1
Austin, Texas 78758
United States
Status: Recruiting Contact: N/A
Facility: Site 2
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A