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Non Small Cell Lung CancerPhase 1NCT04925284

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

A Phase 1 study testing XB002, Nivolumab and Bevacizumab in people with Non Small Cell Lung Cancer and Cervical Cancer, run by Exelixis at 95 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 or bevacizumab to subjects with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, Cervical Cancer, SCCHN
What is being tested?
XB002, Nivolumab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
95 sitesin 9 countries
Study dates
7 Jun 2021to 10 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 21Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

95 sites in 9 countries.

95 sites in 9 countries

United States34 sites

  • Exelixis Clinical Site #23

    Albany, New York, 12206

  • Exelixis Clinical Site #24

    Austin, Texas, 78705

  • Exelixis Clinical Site #1

    Austin, Texas, 78758

  • Exelixis Clinical Site #6

    Baltimore, Maryland, 21287

  • Exelixis Clinical Site #48

    Birmingham, Alabama, 35294

  • Exelixis Clinical Site #25

    Boston, Massachusetts, 02215

  • Exelixis Clinical Site #9

    Charlottesville, Virginia, 22903

  • Exelixis Clinical Site#93

    Chicago, Illinois, 60637

  • Exelixis Clinical Site #15

    Cleveland, Ohio, 44106

  • Exelixis Clinical Site #29

    Cleveland, Ohio, 44195

  • Exelixis Clinical Site #18

    Columbia, Maryland, 21044

  • Exelixis Clinical Site #32

    Dallas, Texas, 75246

  • Exelixis Clinical Site #14

    Dallas, Texas, 75390

  • Exelixis Clinical Site #19

    Detroit, Michigan, 48202

  • Exelixis Clinical Site #10

    Detroit, Michigan, 49201

  • Exelixis Clinical Site #8

    East Brunswick, New Jersey, 08816

  • Exelixis Clinical Site#59

    Fountain Valley, California, 92708

  • Exelixis Clinical Site #49

    Hilliard, Ohio, 43026

  • Exelixis Clinical Site#92

    Houston, Texas, 77030

  • Exelixis Clinical Site#67

    Lake Success, New York, 11042

  • Exelixis Clinical Site#58

    Little Rock, Arkansas, 72205

  • Exelixis Clinical Site #21

    Los Angeles, California, 90025

  • Exelixis Clinical Site #26

    Los Angeles, California, 90404

  • Exelixis Clinical Site #3

    Nashville, Tennessee, 37203

  • Exelixis Clinical Site #7

    New Brunswick, New Jersey, 08903

  • Exelixis Clinical Site #16

    New Haven, Connecticut, 06511

  • Exelixis Clinical Site #12

    New York, New York, 10016

  • Exelixis Clinical Site #4

    Oklahoma City, Oklahoma, 73104

  • Exelixis Clinical Site #11

    Omaha, Nebraska, 68130

  • Exelixis Clinical Site #2

    San Antonio, Texas, 78229

  • Exelixis Clinical Site #5

    St Louis, Missouri, 63110

  • Exelixis Clinical Site #20

    Tucson, Arizona, 85704

  • Exelixis Clinical Site#95

    Tucson, Arizona, 85719

  • Exelixis Clinical Site #22

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain14 sites

  • Exelixis Clinical Site #27

    Barcelona, 08023

  • Exelixis Clinical Site #36

    Barcelona, 08028

  • Exelixis Clinical Site#55

    Barcelona, 8035

  • Exelixis Clinical Site#82

    Barcelona, 8908

  • Exelixis Clinical Site #31

    Lleida, 25198

  • Exelixis Clinical Site#64

    Madrid, 1217

  • Exelixis Clinical Site #17

    Madrid, 28027

  • Exelixis Clinical Site #33

    Madrid, 28040

  • Exelixis Clinical Site #42

    Madrid, 28050

  • Exelixis Clinical Site #13

    Madrid, 28223

  • Exelixis Clinical Site #46

    Málaga, 29010

  • Exelixis Clinical Site #43

    Valencia, 46010

  • Exelixis Clinical Site #51

    Valencia, 46026

  • Exelixis Clinical Site#72

    Zaragoza, 50009

Other trials in Spain

South Korea10 sites

  • Exelixis Clinical Site#79

    Anyang-si, Gyeonggi-do, 14068

  • Exelixis Clinical Site#78

    Hwasun, Jeonranamdo, 58128

  • Exelixis Clinical Site#86

    Pusan, Gyeongsangnam-do, 49201

  • Exelixis Clinical Site#80

    Seongnam-si, Gyeonggi-do, 13496

  • Exelixis Clinical Site#74

    Seongnam-si, Gyeonggido, 13620

  • Exelixis Clinical Site#77

    Seoul, Seoul Teugbyeolsi, 02841

  • Exelixis Clinical Site#94

    Seoul, Seoul Teugbyeolsi, 05505

  • Exelixis Clinical Site#81

    Seoul, Seoul Teugbyeolsi, 06351

  • Exelixis Clinical Site#85

    Seoul, Seoul Teugbyeolsi, 6591

  • Exelixis Clinical Site#83

    Suwon, Gyeonggido, 16247

Other trials in South Korea

France8 sites

  • Exelixis Clinical Site #45

    Bordeaux, 33000

  • Exelixis Clinical Site#69

    Lyon, Auvergne-Rhône-Alpes, 69373

  • Exelixis Clinical Site#87

    Paris, Île-de-France Region, 75013

  • Exelixis Clinical Site #41

    Pierre-Bénite, 69310

  • Exelixis Clinical Site#68

    Poitiers, 86000

  • Exelixis Clinical Site #50

    Rennes, 35042

  • Exelixis Clinical Site#63

    Strasbourg, 67200

  • Exelixis Clinical Site#53

    Villejuif, 94805

Other trials in France

Italy8 sites

  • Exelixis Clinical Site #54

    Ancona, 60126

  • Exelixis Clinical Site#60

    Florence, 50134

  • Exelixis Clinical Site#62

    Milan, MI, 20141

  • Exelixis Clinical Site#84

    Milan, 20132

  • Exelixis Clinical Site #40

    Roma, 00144

  • Exelixis Clinical Site#90

    Roma, 00168

  • Exelixis Clinical Site #34

    Rozzano, 20089

  • Exelixis Clinical Site#61

    Siena, 53100

Other trials in Italy

Belgium6 sites

  • Exelixis Clinical Site#56

    Brussels, 1070

  • Exelixis Clinical Site #30

    Brussels, 1200

  • Exelixis Clinical Site#71

    Charleroi, Hainaut, 6000

  • Exelixis Clinical Site #47

    Edegem, 2650

  • Exelixis Clinical Site #38

    Ghent, 9000

  • Exelixis Clinical Site#66

    Liège, Liege, 4000

Other trials in Belgium

United Kingdom6 sites

  • Exelixis Clinical Site#91

    Cardiff, Wales, CF14 2TL

  • Exelixis Clinical Site #52

    Glasgow, G12 0YN

  • Exelixis Clinical Site#88

    Leicester, England, LE1 5WW

  • Exelixis Clinical Site#89

    London, England, SE1 9RT

  • Exelixis Clinical Site#57

    London, W1T 7HA

  • Exelixis Clinical Site #28

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Australia5 sites

  • Exelixis Clinical Site #37

    Darlinghurst, 2010

  • Exelixis Clinical Site #44

    Liverpool, 2170

  • Exelixis Clinical Site#75

    Miranda, New South Wales, 2228

  • Exelixis Clinical Site#70

    Nedlands, Western Australia, 6009

  • Exelixis Clinical Site #35

    Saint Leonards, 2065

Other trials in Australia

Netherlands4 sites

  • Exelixis Clinical Site#73

    Amsterdam, North Holland, 1066 CX

  • Exelixis Clinical Site#65

    Groningen, 9713 GZ

  • Exelixis Clinical Site #39

    Maastricht, 6229 HX

  • Exelixis Clinical Site#76

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

Official 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

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.

Being tested
XB002, Nivolumab, Bevacizumab
Keywords
ADC, Antibody drug conjugate, Tissue Factor, Auristatin, Nivolumab, bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Pancreatic Neoplasms, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Carcinoma, Ovarian Epithelial, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XB002Drug

    IV administration of XB002

  • NivolumabDrug

    IV administration of Nivolumab

  • BevacizumabDrug

    IV administration of bevacizumab

Study groups in NCT04925284
Study groupRoleWhat they receive
XB002 Single-Agent Dose-Escalation CohortsExperimentalSubjects (Cohort A) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Receives: Drug: XB002
XB002 Single-Agent Expansion CohortsExperimentalThe 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).
Receives: Drug: XB002
XB002 + Nivolumab Dose Escalation CohortsExperimentalSubjects (Cohort AN) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Receives: Drug: XB002; Drug: Nivolumab
XB002 + Nivolumab Dose Expansion CohortsExperimentalThe 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).
Receives: Drug: XB002; Drug: Nivolumab
Experimental: XB002 + Bevacizumab Dose Escalation CohortsExperimentalSubjects (Cohort AB) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Receives: Drug: XB002; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Escalation Stage: MTD/recommended dose for XB002

    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

    Measured: 18 months

  2. Cohort-Expansion Stage: Objective Response Rate (ORR)

    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

    Measured: 12 months

Secondary outcomes (10)

  1. Safety of XB002: Adverse Events

    To evaluate the safety of XB002 through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)

    Measured: 30 months

  2. Tolerability of XB002 as evaluated by the duration of exposure for the study

    To evaluate the tolerability of XB002 through the evaluation of duration of exposure for the study treatment

    Measured: 30 months

  3. Tolerability of XB002 as evaluated dose intensity of the study treatment

    To evaluate the tolerability of XB002 through the evaluation of dose intensity of the study treatment

    Measured: 30 months

  4. Maximum Plasma Concentration (Cmax)

    To evaluate the Cmax for XB002, total antibody, and free payload at scheduled visits over time

    Measured: 30 months

  5. Trough Concentration (Ctrough)

    To evaluate the Ctrough of XB002, total antibody, and free payload at scheduled visits over time

    Measured: 30 months

  6. Immunogenicity of XB002

    To assess the immunogenicity of XB002 as measured by anti-drug antibody (ADA) analysis

    Measured: 30 months

  7. Anti-tumor activity of XB002: Objective Response Rate (ORR)

    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).

    Measured: 30 months

  8. Anti-tumor activity of XB002: Duration of Response (DOR)

    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)

    Measured: 30 months

  9. Anti-tumor activity of XB002: Progression Free Survival (PFS)

    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)

    Measured: 30 months

  10. Cohort-Expansion Stage: overall survival

    To evaluate overall survival

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start7 Jun 2021
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Dose-escalation followed by cohort-expansion in tumor-specific expansion cohorts
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925284
Sponsor's protocol ID
XB002-101
Status last verified
Apr 2025
First submitted
27 May 2021
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XB002, Nivolumab and Bevacizumab in people with Non Small Cell Lung Cancer and Cervical Cancer, run by Exelixis at 95 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Spain, South Korea, France, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Escalation Stage: MTD/recommended dose for XB002 (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04925284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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