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Monoclonal Antibodies

Tucatinib for Colorectal Cancer

Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 49.3 months
Awards & highlights

Summary

This trial is studying how well tucatinib works with or without trastuzumab to treat participants with HER2-positive metastatic colorectal cancer.

Eligible Conditions
  • Metastatic Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 49.3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 49.3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (cORR) Per RECIST 1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B
Secondary outcome measures
Duration of Response (DOR) Per RECIST 1.1 According to BICR Assessment
Number of Participants With AEs Resulting in Dose Modification
Number of Participants With Adverse Events (AEs)
+5 more

Side effects data

From 2023 Phase 2 trial • 117 Patients • NCT03043313
64%
Diarrhoea
43%
Fatigue
34%
Nausea
21%
Infusion related reaction
20%
Pyrexia
19%
Chills
19%
Decreased appetite
19%
Dermatitis acneiform
17%
Hypertension
16%
Arthralgia
16%
Vomiting
16%
Back pain
16%
Cough
14%
Abdominal pain
14%
Constipation
14%
Dyspnoea
13%
Myalgia
10%
Anaemia
10%
Anxiety
9%
Pain in extremity
9%
Headache
9%
Dry skin
9%
Pruritus
8%
Peripheral sensory neuropathy
8%
Insomnia
8%
Rash maculo-papular
8%
Influenza like illness
8%
Dehydration
8%
Oedema peripheral
8%
Nasal congestion
7%
Upper-airway cough syndrome
7%
Productive cough
7%
Weight decreased
7%
Muscle spasms
7%
Epistaxis
6%
Hypokalaemia
6%
Rhinitis allergic
6%
COVID-19
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
5%
Dizziness
5%
Dry mouth
5%
Abdominal pain upper
5%
Ejection fraction decreased
5%
Musculoskeletal chest pain
5%
Nephrolithiasis
5%
Oropharyngeal pain
5%
Rash
5%
Haematuria
5%
Urinary tract infection
5%
Dysgeusia
5%
Flank pain
3%
Dyspepsia
3%
Gastrooesophageal reflux disease
3%
Large intestinal obstruction
3%
Flatulence
3%
Asthenia
3%
Dysuria
3%
Vision Blurred
3%
Non-cardiac chest pain
3%
Fall
3%
Blood creatinine increased
3%
Pollakiuria
3%
Small intestinal obstruction
3%
Hyponatraemia
3%
Rhinorrhoea
3%
Wheezing
3%
Hypercreatinaemia
2%
Abdominal discomfort
2%
Blepharospasm
2%
Gastrointestinal pain
2%
Pelvic pain
2%
Onychomadesis
2%
Abdominal distension
2%
Thrombocytopenia
2%
Rectal haemorrhage
2%
Peripheral swelling
2%
COVID-19 pneumonia
2%
Herpes zoster
2%
Influenza
2%
Nail infection
2%
Rhinitis
2%
Blood alkaline phosphatase increased
2%
Rectal perforation
2%
Muscular weakness
2%
Weight increased
2%
Dysphonia
2%
Erythema
2%
Nail disorder
2%
Urticaria
2%
Hypoalbuminaemia
2%
Dyspnoea exertional
2%
Pulmonary embolism
2%
Sinus pain
1%
Bile duct stone
1%
Cholangitis
1%
Sepsis
1%
Cancer pain
1%
Acute kidney injury
1%
Hypotension
1%
Angina unstable
1%
Colitis
1%
Gastrointestinal obstruction
1%
Kidney infection
1%
Renal colic
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tucatinib+Trastuzumab (Cohorts A+B)
Cohort C (Pre-Crossover)
Cohort C (Post-Crossover)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: Tucatinib MonotherapyExperimental Treatment1 Intervention
Randomized cohort. Participants take tucatinib twice per orally every day. Participants who do not respond to therapy may have the option to receive tucatinib and trastuzumab.
Group II: Cohort B: Tucatinib + TrastuzumabExperimental Treatment2 Interventions
Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
Group III: Cohort A: Tucatinib + TrastuzumabExperimental Treatment2 Interventions
Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Tucatinib
2017
Completed Phase 2
~520

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,603 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,883 Total Patients Enrolled
Academic and Community Cancer Research UnitedOTHER
53 Previous Clinical Trials
4,884 Total Patients Enrolled

Media Library

Trastuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03043313 — Phase 2
Colorectal Cancer Research Study Groups: Cohort A: Tucatinib + Trastuzumab, Cohort B: Tucatinib + Trastuzumab, Cohort C: Tucatinib Monotherapy
Colorectal Cancer Clinical Trial 2023: Trastuzumab Highlights & Side Effects. Trial Name: NCT03043313 — Phase 2
Trastuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03043313 — Phase 2
~14 spots leftby Sep 2025
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