Study Of XB002 In Subjects With Solid Tumors (JEWEL-101)

Study Overview

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

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.

N/A

Non Small Cell Lung Cancer
Cervical Cancer
SCCHN
Pancreatic Cancer
Esophageal SCC
Metastatic Castration-resistant Prostate Cancer
Triple Negative Breast Cancer
Hormone Receptor-positive Breast Cancer
Epithelial Ovarian Cancer
Endometrial Cancer
Tissue Factor-Expressing Solid Tumors

DRUG: XB002
DRUG: Nivolumab
DRUG: Bevacizumab

XB002-101

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-02
First Submitted that Met QC Criteria 2021-06-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-04
First Posted (ACTUAL) 2021-06-14	Results First Posted N/A	Last Verified 2025-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

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 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 (Cohor	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 + 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

Primary Outcome Measures	Measure Description	Time Frame
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	18 months
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	12 months

Secondary Outcome Measures	Measure Description	Time Frame
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)	30 months
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	30 months
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	30 months
Maximum Plasma Concentration (Cmax)	To evaluate the Cmax for XB002, total antibody, and free payload at scheduled visits over time	30 months
Trough Concentration (Ctrough)	To evaluate the Ctrough of XB002, total antibody, and free payload at scheduled visits over time	30 months
Immunogenicity of XB002	To assess the immunogenicity of XB002 as measured by anti-drug antibody (ADA) analysis	30 months
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).	30 months
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)	30 months
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)	30 months
Cohort-Expansion Stage: overall survival	To evaluate overall survival	12 months

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

Publications

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