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Study of XB002 in Subjects With Solid Tumors

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ClinicalTrials.gov Identifier: NCT04925284
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Urothelial Cancer Epithelial Ovarian Cancer Cervical Cancer SCCHN Pancreatic Cancer Drug: XB002 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 199 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose-escalation followed by cohort-expansion in tumor-specific expansion cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : June 7, 2024
Estimated Study Completion Date : October 7, 2024


Arm Intervention/treatment
Experimental: XB002 Dose-Escalation Cohorts
Subjects (Cohort A) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Drug: XB002
IV administration of XB002

Experimental: XB002 Expansion Cohorts
The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with non-small cell lung cancer [NSCLC] (Cohort B), urothelial cancer (Cohort C), epithelial ovarian cancer [EOC] (Cohort D), cervical cancer (Cohort E), SCCHN (Cohort F) and pancreatic cancer (cohort G)
Drug: XB002
IV administration of XB002




Primary Outcome Measures :
  1. Dose-Escalation Stage: MTD/recommended dose for XB002 [ Time Frame: 18 months ]
    To determine the MTD and/or RD for further evaluation of IV administration of XB002 in subjects with advanced malignancies

  2. Cohort-Expansion Stage: Objective Response Rate (ORR) [ Time Frame: 12 months ]
    To evaluate preliminary efficacy of XB002 by estimating the ORR per RECIST 1.1 as assessed by the Investigator


Secondary Outcome Measures :
  1. Safety of XB002: Adverse Events [ Time Frame: 30 months ]
    To evaluate the safety of XB002 through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)

  2. Tolerability of XB002 as evaluated by the duration of exposure for the study [ Time Frame: 30 months ]
    To evaluate the tolerability of XB002 through the evaluation of duration of exposure for the study treatment

  3. Tolerability of XB002 as evaluated dose intensity of the study treatment [ Time Frame: 30 months ]
    To evaluate the tolerability of XB002 through the evaluation of dose intensity of the study treatment

  4. Maximum Plasma Concentration (Cmax) [ Time Frame: 30 months ]
    To evaluate the Cmax for XB002, total antibody, and free payload at scheduled visits over time

  5. Trough Concentration (Ctrough) [ Time Frame: 30 months ]
    To evaluate the Ctrough of XB002, total antibody, and free payload at scheduled visits over time

  6. Immunogenicity of XB002 [ Time Frame: 30 months ]
    To assess the immunogenicity of XB002 as measured by anti-drug antibody (ADA) analysis

  7. Dose-Escalation Stage: Anti-tumor activity of XB002: Objective Response Rate (ORR) [ Time Frame: 30 months ]
    To evaluate the anti-tumor activity of XB002, as measured by ORR, per RECIST 1.1 as assessed by the Investigator

  8. Anti-tumor activity of XB002: Duration of Response (DOR) [ Time Frame: 30 months ]
    To evaluate the anti-tumor activity of XB002, as measured by DOR, per RECIST 1.1 as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)

  9. Anti-tumor activity of XB002: Progression Free Survival (PFS) [ Time Frame: 30 months ]
    To evaluate the anti-tumor activity of XB002, as measured by PFS, per RECIST 1.1 as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)

  10. Cohort-Expansion Stage: overall survival [ Time Frame: 12 months ]
    To evaluate overall survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925284


Contacts
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Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494) druginfo@exelixis.com
Contact: Backup or International 650-837-7400

Locations
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United States, Tennessee
Site 3 Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Site 1 Recruiting
Austin, Texas, United States, 78758
Site 2 Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Exelixis
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Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT04925284    
Other Study ID Numbers: XB002-101
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type