Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RC48, RC48-ADC
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 2: HR+, HER2-low locally advanced or metastatic breast cancer | EXPERIMENTAL | disitamab vedotin monotherapy |
| Cohort 1: HER2+ 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...
Disitamab vedotin is an investigational antibody-drug conjugate being developed by Pfizer for HER2-expressing cancers. It is being studied in breast cancer, non-small-cell lung cancer, urothelial carcinoma, and other solid tumors. It is not yet approved and remains in clinical development.
Disitamab vedotin is being studied for the treatment of HER2-expressing advanced breast cancer, non-small-cell lung cancer, urothelial carcinoma, and other solid tumors. It is an investigational therapy and has not been approved for any indication.
Disitamab vedotin targets HER2, a receptor that is overexpressed in certain cancers. It is an antibody-drug conjugate, meaning it combines an antibody that binds HER2 with a cytotoxic payload to deliver treatment directly to HER2-expressing tumor cells.
Disitamab vedotin is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating the drug in HER2-expressing solid tumors.
Disitamab vedotin is in clinical development across Phase 1, Phase 2, and Phase 3 trials. It is investigational and has not been approved by the FDA. The Phase 3 trial is evaluating it in combination with pembrolizumab versus chemotherapy in previously untreated urothelial cancer.
Disitamab vedotin is being studied in four active trials: NCT06966453 in HER2-expressing advanced breast cancer, NCT06157892 in solid tumors including breast and gastric cancers, NCT06003231 in previously treated HER2-expressing solid tumors, and NCT05911295 in urothelial carcinoma. All are active but not recruiting.