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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04925284




Registration number
NCT04925284
Ethics application status
Date submitted
27/05/2021
Date registered
14/06/2021
Date last updated
3/05/2024

Titles & IDs
Public title
Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
Scientific title
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
Secondary ID [1] 0 0
XB002-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Cervical Cancer 0 0
SCCHN 0 0
Pancreatic Cancer 0 0
Esophageal SCC 0 0
Metastatic Castration-resistant Prostate Cancer 0 0
Triple Negative Breast Cancer 0 0
Hormone Receptor-positive Breast Cancer 0 0
Epithelial Ovarian Cancer 0 0
Endometrial Cancer 0 0
Tissue Factor-Expressing Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XB002
Treatment: Drugs - Nivolumab

Experimental: XB002 Single-Agent Dose-Escalation Cohorts - Subjects (Cohort A) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.

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).

Experimental: XB002 + Nivolumab Dose Escalation Cohorts - Subjects (Cohort AN) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.

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), Esophageal SCC (Cohort HN).


Treatment: Drugs: XB002
IV administration of XB002

Treatment: Drugs: Nivolumab
IV administration of Nivolumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-Escalation Stage: MTD/recommended dose for XB002
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Cohort-Expansion Stage: Objective Response Rate (ORR)
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Safety of XB002: Adverse Events
Timepoint [1] 0 0
30 months
Secondary outcome [2] 0 0
Tolerability of XB002 as evaluated by the duration of exposure for the study
Timepoint [2] 0 0
30 months
Secondary outcome [3] 0 0
Tolerability of XB002 as evaluated dose intensity of the study treatment
Timepoint [3] 0 0
30 months
Secondary outcome [4] 0 0
Maximum Plasma Concentration (Cmax)
Timepoint [4] 0 0
30 months
Secondary outcome [5] 0 0
Trough Concentration (Ctrough)
Timepoint [5] 0 0
30 months
Secondary outcome [6] 0 0
Immunogenicity of XB002
Timepoint [6] 0 0
30 months
Secondary outcome [7] 0 0
Anti-tumor activity of XB002: Objective Response Rate (ORR)
Timepoint [7] 0 0
30 months
Secondary outcome [8] 0 0
Anti-tumor activity of XB002: Duration of Response (DOR)
Timepoint [8] 0 0
30 months
Secondary outcome [9] 0 0
Anti-tumor activity of XB002: Progression Free Survival (PFS)
Timepoint [9] 0 0
30 months
Secondary outcome [10] 0 0
Cohort-Expansion Stage: overall survival
Timepoint [10] 0 0
12 months

Eligibility
Key inclusion criteria
- Cytologically or histologically and radiologically confirmed solid tumor that is
inoperable, locally advanced, metastatic, or recurrent.

- Dose-Escalation Stage Cohorts A and AN: The subject has received atleast 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.

- Cohorts H and HN (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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/10/2024
Actual
Sample size
Target
573
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Exelixis Clinical Site#75 - Miranda
Recruitment hospital [2] 0 0
Exelixis Clinical Site#70 - Nedlands
Recruitment hospital [3] 0 0
Exelixis Clinical Site #37 - Darlinghurst
Recruitment hospital [4] 0 0
Exelixis Clinical Site #44 - Liverpool
Recruitment hospital [5] 0 0
Exelixis Clinical Site #35 - Saint Leonards
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2065 - Saint Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Belgium
State/province [19] 0 0
Hainaut
Country [20] 0 0
Belgium
State/province [20] 0 0
Liege
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
France
State/province [24] 0 0
Ile-de-France
Country [25] 0 0
France
State/province [25] 0 0
Rhone-Alpes
Country [26] 0 0
France
State/province [26] 0 0
Bordeaux
Country [27] 0 0
France
State/province [27] 0 0
Pierre Benite
Country [28] 0 0
France
State/province [28] 0 0
Poitiers
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg
Country [31] 0 0
France
State/province [31] 0 0
Villejuif
Country [32] 0 0
Italy
State/province [32] 0 0
MI
Country [33] 0 0
Italy
State/province [33] 0 0
Ancona
Country [34] 0 0
Italy
State/province [34] 0 0
Firenze
Country [35] 0 0
Italy
State/province [35] 0 0
Milan
Country [36] 0 0
Italy
State/province [36] 0 0
Roma
Country [37] 0 0
Italy
State/province [37] 0 0
Rozzano
Country [38] 0 0
Italy
State/province [38] 0 0
Siena
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Gyeonggi-do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gyeonggi-Do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Gyeonggido [Kyonggi-do]
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Gyeongsangnam-do
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Jeonranamdo [Chollanam-do]
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Country [45] 0 0
Netherlands
State/province [45] 0 0
Noord-Holland
Country [46] 0 0
Netherlands
State/province [46] 0 0
Zuid-Holland
Country [47] 0 0
Netherlands
State/province [47] 0 0
Groningen
Country [48] 0 0
Netherlands
State/province [48] 0 0
Maastricht
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Lleida
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
Spain
State/province [52] 0 0
Málaga
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Spain
State/province [54] 0 0
Zaragoza
Country [55] 0 0
United Kingdom
State/province [55] 0 0
England
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Wales
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Glasgow
Country [58] 0 0
United Kingdom
State/province [58] 0 0
London
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Exelixis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 to subjects with advanced solid
tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04925284
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Exelixis Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
1-888-EXELIXIS (888-393-5494)
Fax 0 0
Email 0 0
druginfo@exelixis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04925284