Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04925284 | Study of XB002 in Subjects With Solid Tumors (JEWEL-101) | PHASE1 | COMPLETED | 269 | — | — | Jun 7, 2021 | Mar 10, 2025 | Apr 4, 2025 | 95 | United States, Australia +7 |
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
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
| Arm | Type | Description |
|---|---|---|
| XB002 Single-Agent Dose-Escalation Cohorts | EXPERIMENTAL | Subjects (Cohort A) will accrue in cohorts of 3-12 subjects in a modified i3+3 design. |
| XB002 Single-Agent Expansion Cohorts | EXPERIMENTAL | 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). |
| XB002 + Nivolumab Dose Escalation Cohorts | EXPERIMENTAL | Subjects (Cohort AN) will accrue in cohorts of 3-12 subjects in a modified i3+3 design. |
| XB002 + Nivolumab Dose Expansion Cohorts | EXPERIMENTAL | 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: XB002 + Bevacizumab Dose Escalation Cohorts | EXPERIMENTAL | Subjects (Cohort AB) will accrue in cohorts of 3-12 subjects in a modified i3+3 design. |
| Name | Type | Description |
|---|---|---|
| XB002 | DRUG | IV administration of XB002 |
| Nivolumab | DRUG | IV administration of Nivolumab |
| Bevacizumab | DRUG | IV administration of bevacizumab |
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 doe...