Study of XB002 in Subjects With Solid Tumors (JEWEL-101)

April 2, 2025 updated by: Exelixis

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

This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

269

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia, 2010
        • Exelixis Clinical Site #37
      • Liverpool, Australia, 2170
        • Exelixis Clinical Site #44
      • Saint Leonards, Australia, 2065
        • Exelixis Clinical Site #35
    • New South Wales
      • Miranda, New South Wales, Australia, 2228
        • Exelixis Clinical Site#75
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Exelixis Clinical Site#70
  • Belgium
      • Brussels, Belgium, 1070
        • Exelixis Clinical Site#56
      • Brussels, Belgium, 1200
        • Exelixis Clinical Site #30
      • Edegem, Belgium, 2650
        • Exelixis Clinical Site #47
      • Gent, Belgium, 9000
        • Exelixis Clinical Site #38
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Exelixis Clinical Site#71
    • Liege
      • Liège, Liege, Belgium, 4000
        • Exelixis Clinical Site#66
  • France
      • Bordeaux, France, 33000
        • Exelixis Clinical Site #45
      • Pierre Benite, France, 69310
        • Exelixis Clinical Site #41
      • Poitiers, France, 86000
        • Exelixis Clinical Site#68
      • Rennes, France, 35042
        • Exelixis Clinical Site #50
      • Strasbourg, France, 67200
        • Exelixis Clinical Site#63
      • Villejuif, France, 94805
        • Exelixis Clinical Site#53
    • Ile-de-France
      • Paris, Ile-de-France, France, 75013
        • Exelixis Clinical Site#87
    • Rhone-Alpes
      • Lyon, Rhone-Alpes, France, 69373
        • Exelixis Clinical Site#69
  • Italy
      • Ancona, Italy, 60126
        • Exelixis Clinical Site #54
      • Firenze, Italy, 50134
        • Exelixis Clinical Site#60
      • Milan, Italy, 20132
        • Exelixis Clinical Site#84
      • Roma, Italy, 00144
        • Exelixis Clinical Site #40
      • Roma, Italy, 00168
        • Exelixis Clinical Site#90
      • Rozzano, Italy, 20089
        • Exelixis Clinical Site #34
      • Siena, Italy, 53100
        • Exelixis Clinical Site#61
    • MI
      • Milano, MI, Italy, 20141
        • Exelixis Clinical Site#62
  • Korea, Republic of
    • Gyeonggi-Do
      • Seongnam-si, Gyeonggi-Do, Korea, Republic of, 13496
        • Exelixis Clinical Site#80
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
        • Exelixis Clinical Site#79
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
        • Exelixis Clinical Site#74
      • Suwon, Gyeonggido, Korea, Republic of, 16247
        • Exelixis Clinical Site#83
    • Gyeongsangnam-do
      • Busan, Gyeongsangnam-do, Korea, Republic of, 49201
        • Exelixis Clinical Site#86
    • Jeonranamdo
      • Hwasun, Jeonranamdo, Korea, Republic of, 58128
        • Exelixis Clinical Site#78
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
        • Exelixis Clinical Site#77
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Exelixis Clinical Site#94
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Exelixis Clinical Site#81
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 6591
        • Exelixis Clinical Site#85
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Exelixis Clinical Site#65
      • Maastricht, Netherlands, 6229 HX
        • Exelixis Clinical Site #39
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066 CX
        • Exelixis Clinical Site#73
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Exelixis Clinical Site#76
  • Spain
      • Barcelona, Spain, 08023
        • Exelixis Clinical Site #27
      • Barcelona, Spain, 08028
        • Exelixis Clinical Site #36
      • Barcelona, Spain, 8035
        • Exelixis Clinical Site#55
      • Barcelona, Spain, 8908
        • Exelixis Clinical Site#82
      • Lleida, Spain, 25198
        • Exelixis Clinical Site #31
      • Madrid, Spain, 1217
        • Exelixis Clinical Site#64
      • Madrid, Spain, 28027
        • Exelixis Clinical Site #17
      • Madrid, Spain, 28040
        • Exelixis Clinical Site #33
      • Madrid, Spain, 28050
        • Exelixis Clinical Site #42
      • Madrid, Spain, 28223
        • Exelixis Clinical Site #13
      • Málaga, Spain, 29010
        • Exelixis Clinical Site #46
      • Valencia, Spain, 46010
        • Exelixis Clinical Site #43
      • Valencia, Spain, 46026
        • Exelixis Clinical Site #51
      • Zaragoza, Spain, 50009
        • Exelixis Clinical Site#72
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Exelixis Clinical Site #52
      • London, United Kingdom, W1T 7HA
        • Exelixis Clinical Site#57
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Exelixis Clinical Site #28
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Exelixis Clinical Site#88
      • London, England, United Kingdom, SE1 9RT
        • Exelixis Clinical Site#89
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Exelixis Clinical Site#91
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Exelixis Clinical Site #48
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Exelixis Clinical Site #20
      • Tucson, Arizona, United States, 85719
        • Exelixis Clinical Site#95
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Exelixis Clinical Site#58
    • California
      • Fountain Valley, California, United States, 92708
        • Exelixis Clinical Site#59
      • Los Angeles, California, United States, 90025
        • Exelixis Clinical Site #21
      • Los Angeles, California, United States, 90404
        • Exelixis Clinical Site #26
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Exelixis Clinical Site #16
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Exelixis Clinical Site #22
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Exelixis Clinical Site#93
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Exelixis Clinical Site #6
      • Columbia, Maryland, United States, 21044
        • Exelixis Clinical Site #18
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Exelixis Clinical Site #25
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Exelixis Clinical Site #19
      • Detroit, Michigan, United States, 49201
        • Exelixis Clinical Site #10
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Exelixis Clinical Site #5
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Exelixis Clinical Site #11
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Exelixis Clinical Site #8
      • New Brunswick, New Jersey, United States, 08903
        • Exelixis Clinical Site #7
    • New York
      • Albany, New York, United States, 12206
        • Exelixis Clinical Site #23
      • Lake Success, New York, United States, 11042
        • Exelixis Clinical Site#67
      • New York, New York, United States, 10016
        • Exelixis Clinical Site #12
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Exelixis Clinical Site #15
      • Cleveland, Ohio, United States, 44195
        • Exelixis Clinical Site #29
      • Hilliard, Ohio, United States, 43026
        • Exelixis Clinical Site #49
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Exelixis Clinical Site #4
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Exelixis Clinical Site #3
    • Texas
      • Austin, Texas, United States, 78705
        • Exelixis Clinical Site #24
      • Austin, Texas, United States, 78758
        • Exelixis Clinical Site #1
      • Dallas, Texas, United States, 75246
        • Exelixis Clinical Site #32
      • Dallas, Texas, United States, 75390
        • Exelixis Clinical Site #14
      • Houston, Texas, United States, 77030
        • Exelixis Clinical Site#92
      • San Antonio, Texas, United States, 78229
        • Exelixis Clinical Site #2
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Exelixis Clinical Site #9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.
  • Dose-Escalation Stage Cohorts A, AB, and AN: The subject has received at least one systemic standard life-prolonging therapy unless it does not exist, or available therapies are intolerable or no longer effective.
  • Cohort-Expansion Stage (Cohorts B - M, BN, FN and HN): 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 and BN (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 D (Epithelial Ovarian Cancer): Subjects with high-grade serous ovarian cancer, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) who have platinum-resistant disease following treatment with platinum-containing chemotherapy.
  • Cohort-Expansion Stage Cohort E (Cervical Cancer): Subjects with persistent, recurrent, or metastatic carcinoma of the uterine cervix who have documented radiographic disease progression during or following their last systemic anticancer therapy.
  • Cohorts F and FN (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.
  • Cohort H (Esophageal SCC): Subjects with esophageal cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. Note: subjects with esophageal adenocarcinoma and adenocarcinoma of gastroesophageal junction (GEJ) are excluded.
  • Cohort I (mCRPC): Subjects with metastatic, castration resistant adenocarcinoma of the prostate. Note: Neuroendocrine differentiation and other histological features are permitted if adenocarcinoma is the primary histology.
  • Cohort J (TNBC): Subjects with triple-negative (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/ human epidermal growth factor receptor 2 negative [HER-2-]) breast cancer who have documented radiographic disease progression during or following their last systemic anticancer therapy for inoperable locally advanced or metastatic disease.
  • Cohort K (HR + BC): Subjects with breast cancer that is hormone receptor-positive (ER+ and/or PR+) and HER-2-) and who have documented radiographic disease progression during or following their last systemic anticancer therapy for inoperable locally advanced or metastatic disease.
  • Cohort L (Endometrial Cancer): Subjects with locally advanced, recurrent or metastatic endometrial cancer who have documented radiographic disease progression during or following their last systemic anticancer therapy.
  • Cohort M (Tumor-Agnostic Tissue Factor-Expressing Solid Tumors): Subjects with solid tumors other than those designated in Cohorts B-L and those which express tissue factor. Participation in this cohort will be at selected sites and countries based on site feasibility assessment.
  • Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1 as determined by the Investigator, except for subjects with prostate cancer without soft tissue disease and subjects with primary brain tumors.
  • Tumor tissue material collected no more than 3 years prior to consent, if possible. If archival tumor tissue is not available, a fresh tumor biopsy may be collected from subjects enrolled in the Dose-Escalation Stage and should be collected from subjects in the Cohort-Expansion Stage.
  • 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.
  • Major surgery within 4 weeks before first dose of study treatment
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG).
  • Pregnant or lactating females
  • Previously identified allergy or hypersensitivity to components of study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies.
  • Another unresolved malignancy or a malignancy that is considered to be cured within 2 years before first dose of study treatment. Note: Subjects with superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy within 2 years before first dose of study treatment are eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XB002 Single-Agent 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 + Nivolumab Dose Escalation Cohorts
Subjects (Cohort AN) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Drug: XB002
IV administration of XB002
Drug: Nivolumab
IV administration of Nivolumab
Experimental: XB002 Single-Agent 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), epithelial ovarian cancer (Cohort D), cervical cancer (Cohort E), SCCHN (Cohort F), pancreatic cancer (Cohort G), Esophageal SCC (Cohort H), metastatic castration-resistant prostate cancer (Cohort I), triple-negative breast cancer (Cohort J), hormone-receptor positive breast cancer (Cohort K), endometrial cancer (Cohort L) and tumor agnostic tissue factor-expressing solid tumors (Cohort M).
Drug: XB002
IV administration of XB002
Experimental: XB002 + Nivolumab Dose 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 BN), SCCHN (Cohort FN).
Drug: XB002
IV administration of XB002
Drug: Nivolumab
IV administration of Nivolumab
Experimental: Experimental: XB002 + Bevacizumab Dose Escalation Cohorts
Subjects (Cohort AB) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Drug: XB002
IV administration of XB002
Drug: Bevacizumab
IV administration of bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 alone and in combination therapy in subjects with advanced malignancies
18 months
Cohort-Expansion Stage: Objective Response Rate (ORR)
Time Frame: 12 months
To evaluate preliminary efficacy of XB002 when administered alone and in combination therapy by determining the ORR per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 months
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
30 months
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
30 months
Maximum Plasma Concentration (Cmax)
Time Frame: 30 months
To evaluate the Cmax for XB002, total antibody, and free payload at scheduled visits over time
30 months
Trough Concentration (Ctrough)
Time Frame: 30 months
To evaluate the Ctrough of XB002, total antibody, and free payload at scheduled visits over time
30 months
Immunogenicity of XB002
Time Frame: 30 months
To assess the immunogenicity of XB002 as measured by anti-drug antibody (ADA) analysis
30 months
Cohort-Expansion Stage: overall survival
Time Frame: 12 months
To evaluate overall survival
12 months
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 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage).
30 months
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 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)
30 months
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 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

March 10, 2025

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XB002-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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