A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

← catalyst calendar

NCT05253651 · readout in 499 d

Sponsored by Seagen, a wholly owned subsidiary of Pfizer (industry) · PFE — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

400estimated

Sites

366

Countries

Argentina, Australia, Austria +22

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

2022-10-24

actual

When the study began enrolling

Primary completion

2027-12-31

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-07-03

estimated

The whole study's end, after follow-up

First posted

2022-02-24

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

Condition

Colorectal Neoplasms

Interventions

Drug: tucatinib — also filed as TUKYSA, ONT-380, ARRY-380, PF-07265792
Drug: trastuzumab — also filed as Herceptin
Drug: bevacizumab — also filed as Avastin
Drug: cetuximab — also filed as Erbitux
Drug: oxaliplatin
Drug: leucovorin
Drug: levoleucovorin
Drug: fluorouracil

Primary outcome

what the primary-completion date above is the date OF

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)

measured Up to approximately 3 years

Publications

PMID 39723627 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

Permalink · PFE's whole pipeline · Catalyst calendar · Every registered study · What changed