# DESTINY-CRC01

Source: https://onco.cc/trials/destiny-crc01/  
OnCo record `destiny-crc01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first trial of the HER2 antibody-drug conjugate in bowel cancer. Almost half the strongly HER2-positive tumours shrank, including some that had already failed other HER2 drugs.

## Summary

DESTINY-CRC01 enrolled 78 treated patients into three cohorts by HER2 expression: cohort A (IHC 3+ or IHC 2+ and ISH-positive, 53 patients), cohort B (IHC 2+, ISH-negative, seven) and cohort C (IHC 1+, 18). In cohort A the confirmed objective response rate was 45.3 percent (95% CI 31.6 to 59.6) after a median 27.1 weeks. Grade 3 or worse events in at least a tenth of participants were decreased neutrophil count (22 percent) and anaemia (14 percent); five patients (6 percent) had adjudicated interstitial lung disease or pneumonitis, two of them fatal, the only treatment-related deaths. DESTINY-CRC02 then tested the lower 5.4 mg/kg dose (response 37.8 percent) which is the dose in the April 2024 tumour-agnostic HER2 IHC 3+ accelerated approval.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Registry id: NCT03384940
- Phase: 2
- Setting: HER2-expressing metastatic colorectal cancer, RAS and BRAF V600E wild-type, after two or more previous regimens: trastuzumab deruxtecan 6.4 mg/kg, in three cohorts by HER2 level
- Sponsor: Daiichi Sankyo
- Enrolled: 86
- Result: Confirmed objective response 45.3 percent in HER2-positive disease; interstitial lung disease in 6 percent, two deaths.
- Outcomes: Confirmed objective response rate (cohort A, HER2-positive): Trastuzumab deruxtecan 6.4 mg/kg 45.3 percent
- Replication: DESTINY-CRC02 confirmed activity at 5.4 mg/kg (ORR 37.8 percent) with a better safety profile.

## Sources

- ClinicalTrials.gov NCT03384940: https://clinicaltrials.gov/study/NCT03384940
- DESTINY-CRC01: trastuzumab deruxtecan in HER2-expressing metastatic colorectal cancer (Lancet Oncology 2021): https://doi.org/10.1016/S1470-2045(21)00086-3

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [HER2-amplified colorectal cancer](https://onco.cc/cancers/her2-amplified-colorectal/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- terms: [Tumour-agnostic (tissue-agnostic) approval](https://onco.cc/terms/tumour-agnostic/)
- trials: [DESTINY-CRC02](https://onco.cc/trials/destiny-crc02/), [MOUNTAINEER](https://onco.cc/trials/mountaineer/), [TRIUMPH](https://onco.cc/trials/triumph/)

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