Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XB002 · 1 trial · 11 indications
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...
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XB002 is being studied for the treatment of non small cell lung cancer and other tissue factor-expressing solid tumors. It is an investigational small molecule developed by Exelixis, Inc. and has been evaluated in a Phase 1 clinical trial in adults with advanced solid tumors.
XB002 is developed by Exelixis, Inc., which trades on the Nasdaq under the ticker EXEL. The company is the sponsor of the clinical program evaluating XB002 in solid tumors, including non small cell lung cancer.
XB002 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program has completed, with one trial listed as completed and no active trials currently reported.
XB002 has been studied in the Phase 1 JEWEL-101 trial, registered as NCT04925284. That trial enrolled 269 participants with solid tumors, including non small cell lung cancer, and was conducted across the United States, Australia, Belgium, France, Italy, the Netherlands, South Korea, Spain, and the United Kingdom.
The JEWEL-101 trial of XB002 was a controlled, randomized Phase 1 study that enrolled 269 adults aged 18 years and older with tissue factor-expressing solid tumors. It was not double blinded, did not enroll healthy volunteers, and included patients of all sexes.
Yes. The XB002 Phase 1 program was biomarker selected, enrolling patients whose tumors express tissue factor. The JEWEL-101 trial evaluated XB002 across multiple tissue factor-expressing solid tumor types, including non small cell lung cancer, cervical cancer, and pancreatic cancer.