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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• XB002 — DRUG
  IV administration of XB002
• Nivolumab — DRUG
  IV administration of Nivolumab
• Bevacizumab — DRUG
  IV administration of bevacizumab

Study Details

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.

Key Dates

Start date

Jun 7, 2021

Status verified

Apr 2025

Primary completion

Mar 10, 2025

Completion

Mar 10, 2025

Study Design

Enrollment

269 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Dose-Escalation Stage: MTD/recommended dose for XB002 [ Time Frame: 18 months ]

Locations (34)

Find similar trials in Birmingham, AL

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