A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
← catalyst calendarNCT06157892 · readout in 1,073 d
Sponsored by Seagen, a wholly owned subsidiary of Pfizer (industry) · PFE — their whole pipeline →. With RemeGen Co., Ltd..
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
54actual
Sites
135
Countries
Australia, Canada, Germany +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-05-20 | actual | When the study began enrolling |
| Primary completion | 2029-07-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-07-28 | estimated | The whole study's end, after follow-up |
| First posted | 2023-12-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Neoplasms
- Gastroesophageal Junction Adenocarcinoma
- HER2 Low Breast Neoplasms
- HER2 Positive Breast Neoplasms
- Stomach Neoplasms
- Triple Negative Breast Neoplasms
- Metastatic Breast Cancer
- Metastatic Gastric Cancer
- Advanced Breast Cancer
- Advanced Gastric Cancer
Interventions
- Drug: disitamab vedotin — also filed as RC48, RC48-ADC
- Drug: tucatinib — also filed as TUKYSA, ONT-380, ARRY-380
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with dose limiting toxicities (DLTs) in dose escalation phase
measured Up to 28 days
Number of participants with adverse events (AEs)
measured Through 30 days after the last study treatment; approximately 5 years
Number of participants with laboratory abnormalities
measured Through 30-37 days after the last study treatment: approximately 5 years
Number of participants with dose alterations
measured Through 30-37 days after the last study treatment: approximately 5 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
measured Approximately 3 years
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