Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
disitamab vedotin · 5 trials · 16 indications
The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.
The time from date of randomization to date of death due to any cause.
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.
The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
The primary endpoint OR by investigator assessment is defined as the proportion of participants with confirmed CR or PR as determined by investigator per RECIST Version 1.1.
| Arm | Type | Description |
|---|---|---|
| Disitamab vedotin arm | EXPERIMENTAL | disitamab vedotin + pembrolizumab |
| Standard of care arm | ACTIVE_COMPARATOR | gemcitabine + cisplatin OR carboplatin |
| Dose Escalation - Previously treated advanced GC/GEJC or breast cancer | EXPERIMENTAL | disitamab vedotin + tucatinib |
| Dose Optimization - HER2-low and HER2+ LA/mBC | EXPERIMENTAL | disitamab vedotin + tucatinib |
| Dose Optimization - HER2-low and HER2+ LA/mGC/GEJC | EXPERIMENTAL | disitamab vedotin + tucatinib |
| Dose Expansion - HER2-low LA/mBC | EXPERIMENTAL | disitamab vedotin + tucatinib |
| Dose Expansion - HER2+ LA/mBC | EXPERIMENTAL | disitamab vedotin + tucatinib |
| Dose Expansion - HER2-low LA/mGC/GEJC | EXPERIMENTAL | disitamab vedotin + tucatinib |
| Dose Expansion - HER2+ LA/mGC/GEJC | EXPERIMENTAL | disitamab vedotin + tucatinib |
| Head and neck cancer | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Non-small cell lung cancer | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Ovarian cancer | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Endometrial cancer | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort A - DV monotherapy for HER2-positive tumor types | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort B - DV monotherapy for HER2-low tumor types | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort C - Non-randomized combination therapy | EXPERIMENTAL | Disitamab vedotin + pembrolizumab |
| Cohort C - Randomized combination therapy | EXPERIMENTAL | Disitamab vedotin + pembrolizumab |
| Cohort C - Randomized monotherapy | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort D - DV monotherapy (Japan only) | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort E - DV combination therapy (Japan only) | EXPERIMENTAL | Disitamab vedotin + pembrolizumab |
| Cohort G - DV monotherapy | EXPERIMENTAL | Disitamab vedotin |
| Cohort 1: HER2+ locally advanced or metastatic breast cancer | EXPERIMENTAL | disitamab vedotin monotherapy |
| Cohort 2: HR+, HER2-low locally advanced or metastatic breast cancer | EXPERIMENTAL | disitamab vedotin monotherapy |
| Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low locally advanced or metastatic breast cancer | EXPERIMENTAL | disitamab vedotin monotherapy |
| Name | Type | Description |
|---|---|---|
| disitamab vedotin | DRUG | Given into the vein (IV; intravenous) every 2 weeks |
| pembrolizumab | DRUG | 400mg given by IV every 6 weeks |
| gemcitabine | DRUG | 1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycle |
| cisplatin | DRUG | 70 mg\^2 given by IV on day 1 of every 3-week cycle |
| carboplatin | DRUG | Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle |
| tucatinib | DRUG | 300mg given twice daily by mouth (orally) |
Inclusion Criteria: * Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra. * Measurable disease by investigator assessment per RECIST v1.1. * Participant must not ha...