Adults 18 to 100, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) As Assessed By Blinded Independent Central Review (BICR) Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerPrimary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
ORR defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as assessed by blinded independent central review. CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesion based on RECIST v1.1.
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
2
Cohort 2: HER3 Low/Negative (IHC 1+, 0)
0
Duration of Response (DoR) As Assessed by Blinded Independent Central Review (BICR) and Investigator Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
DoR defined as the time from the first documented response (CR or PR) to the date of disease progression or death due to any cause. CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.
Duration of Response: BICR
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
2.91
2.79 – 3.02
Duration of Response: Investigator
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
4.48
2.56 – 6.41
Objective Response Rate (ORR) As Assessed by Investigator Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
ORR defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by Investigator. CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesion based on RECIST v1.1.
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
2
Disease Control Rate (DCR) by Blinded Independent Central Review (BICR) and Investigator Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
DCR is defined as the proportion of participants who achieved a confirmed best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) as assessed by blinded independent central review or by the Investigator. Based on RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of
Disease control rate (BICR)
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
22
Disease control rate (Investigator)
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
22
Time to Tumor Response (TTR) As Assessed by Blinded Independent Central Review (BICR) and Investigator Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
TTR defined as the time from the start of study treatment to the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) that is subsequently confirmed by Blinded Independent Central Review or by the Investigator. CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.
Time to tumor response (BICR)
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
1.99
± 0.813
Time to tumor response (Investigator)
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
1.53
± 0.163
Progression-free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) and Investigator Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
PFS is defined as the time from the start of study treatment to the date of the first documentation of objective PD or death due to any cause, whichever is earlier.
Progression-free survival (BICR)
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
2.27
1.51 – 2.96
Cohort 2: HER3 Low/Negative (IHC 1+, 0)
5.5
Progression-free survival (Investigator)
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
2.53
1.64 – 3.71
Overall Survival (OS) Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
OS defined as the time from the start of study treatment to the date of death due to any cause.
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
10.58
5.36 – 12.09
Cohort 2: HER3 Low/Negative (IHC 1+, 0)
8.9
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Other Safety Parameters During the StudySecondary· From Baseline (Day 0) to data cut off (up to approximately 16.5 months)
TEAEs, study-drug related TEAE, serious adverse events (SAE), study-drug related SAE, and adverse events of special interest (eg. interstitial lung disease and elevation of aminotransferases and total bilirubin) were assessed. A TEAE was defined as an AE with a start or worsening date during the on-treatment period. An SAE was an AE that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Treatment-emergent adverse events (TEAEs)
Group
Value
95% CI
Overall
40
Study-drug related TEAE
Group
Value
95% CI
Overall
37
Serious TEAE (SAE)
Group
Value
95% CI
Overall
17
Study-drug related SAE
Group
Value
95% CI
Overall
9
Adverse event of special interest (AESI)
Group
Value
95% CI
Overall
2
Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)Secondary· At Baseline, and post-Baseline. Post-Baseline including any of the following timepoints- Cycle 1, Days 1&8; Cycles 2&4 and every 2 cycles thereafter, Day 1 (each cycle, 21 days), and at EOT (~16.5 months).
Blood samples were collected to assess the immunogenicity of U3-1402.
Baseline: Positive
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
0
Baseline: Negative
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
37
Baseline: Missing
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
2
Post-baseline: Positive
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
0
Post-baseline: Negative
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
38
Number of Participants Who Have Treatment-emergent Anti-Drug Antibody (ADA)Secondary· At Baseline, and post-Baseline. Post-Baseline including any of the following timepoints- Cycle 1, Days 1&8; Cycles 2&4 and every 2 cycles thereafter, Day 1 (each cycle, 21 days), and at EOT (~16.5 months).
Blood samples were collected to assess the immunogenicity of U3-1402. Treatment-emergent ADA was defined as participants with a negative ADA status at Baseline who had a positive ADA status post-Baseline (treatment-induced ADA), or participants with a positive ADA status at both Baseline and post-Baseline but with an increase of at least 4-fold in ADA titer from Baseline to post-Baseline (treatment-boosted ADA), or participants who had missing ADA data at Baseline and had a positive ADA status post-Baseline.
Treatment-emergent ADA
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
0
Treatment-induced ADA
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
0
Treatment-boosted ADA
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
0
ADA missing at baseline but positive at post-baseline
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
0
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· At baseline (-8 hour to 0 hour), pre-infusion, and 15 minutes, 1 hour, 2 hour, 4 hour, and 8 hour post-infusion of Cycle 1 and Cycle 3 (each cycle is 21 days)
Serum PK parameter Cmax (antibody drug conjugate \[ADC\], total anti-HER3 antibody, and MAAA-1181a) were assessed in the full PK sampling cohort using noncompartmental methods.
U3-1402: Cycle 1
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
155.67
± 43.45
U3-1402: Cycle 3
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
159.80
± 47.94
Total anti-HER3 antibody: Cycle 1
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
154.08
± 32.82
Total anti-HER3 antibody: Cycle 3
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
153.86
± 39.31
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of MAAA-1181a Following Administration of U3-1402 In Participants With Advanced or Metastatic Colorectal CancerSecondary· At baseline (-8 hour to 0 hour), pre-infusion, and 15 minutes, 1 hour, 2 hour, 4 hour, and 8 hour post-infusion of Cycle 1 and Cycle 3 (each cycle is 21 days)
Serum PK parameter Cmax of MAAA-1181a was assessed in the full PK sampling cohort using noncompartmental methods.
Cycle 1
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
38.09
± 19.68
Cycle 3
Group
Value
95% CI
Cohort 1: HER3 High (IHC 3+, 2+)
16.13
± 9.29
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected for approximately 16.5 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06941272 — A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBE
· Phase 1, PHASE2
· recruiting
NCT06469944 — Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First
· Phase 1, PHASE2
· recruiting
NCT06383884 — Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion
· Phase 2
· recruiting
NCT05338970 — HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced E
· Phase 3
· active not recruiting
NCT02980341 — Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast
· Phase 1, PHASE2
· completed
Other recruiting trials for Metastatic Colorectal Cancer
Currently open trials in the same condition.
NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
· Phase 1
· recruiting
NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
· Phase 2
· recruiting
NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma
· Phase 2
· recruiting
NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect
· Phase 2
· recruiting
NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
· recruiting
Other Daiichi Sankyo trials
Trials by the same sponsor.
NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
· Phase 3
· not yet recruiting
NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero
· active not recruiting
NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
· Phase 1, PHASE2
· recruiting
NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv
· Phase 1
· completed
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 18 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04479436.