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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 an investigational small molecule being studied for the treatment of non small cell lung cancer. It is also being evaluated in other tissue factor-expressing solid tumors, including cervical cancer, SCCHN, pancreatic cancer, esophageal SCC, metastatic castration-resistant prostate cancer, triple negative breast cancer, hormone receptor-positive breast cancer, epithelial ovarian cancer, and endometrial cancer.
XB002 targets tissue factor, a protein expressed on the surface of certain solid tumors. By targeting tissue factor, XB002 is designed to deliver a therapeutic effect specifically to cancer cells that express this protein, potentially sparing normal tissues. This mechanism is being investigated in the context of various solid tumor types.
XB002 is being developed by Exelixis, Inc., a biopharmaceutical company. Exelixis is publicly traded on the NASDAQ under the ticker symbol EXEL. The company is conducting clinical research to evaluate the safety and efficacy of XB002 in patients with advanced solid tumors.
XB002 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of XB002 in patients with solid tumors.
XB002 is being studied in a Phase 1 clinical trial with the identifier NCT04925284, titled 'Study of XB002 in Subjects With Solid Tumors (JEWEL-101)'. This trial has been completed and enrolled 269 participants. The study was conducted across multiple countries, including the United States, Australia, Belgium, France, Italy, Netherlands, South Korea, Spain, and the United Kingdom.
No, XB002 is not the same as JEWEL-101. JEWEL-101 is the name of the clinical trial studying XB002, not an alternative name for the drug itself. The trial, with identifier NCT04925284, is a Phase 1 study evaluating XB002 in subjects with solid tumors.