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Chemotherapy

Tucatinib + Trastuzumab + Chemotherapy for Gastrointestinal Cancer

Canton, OH
Phase 2
Waitlist Available
Research Sponsored by Seagen, a wholly owned subsidiary of Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:
Gallbladder carcinoma
Must not have
For Cohorts 2A and 2B: prior anti-HER2 therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether tucatinib is safe when given with other anti-cancer drugs to treat gastrointestinal cancer.

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Who is the study for?
This trial is for adults with HER2+ gastrointestinal cancers, including stomach and colorectal cancer, who can receive oxaliplatin-based chemotherapy. They must have a performance status that allows daily activities with minimal assistance. People cannot join if they've had severe immune-related side effects from certain cancer treatments or are known to be positive for Hepatitis B or C.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of tucatinib combined with trastuzumab and other anti-cancer drugs like pembrolizumab, FOLFOX (a regimen including fluorouracil, leucovorin, and oxaliplatin), and CAPOX (capecitabine plus oxaliplatin). It aims to see how well these combinations work against various types of gastrointestinal cancers.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medications used, potential liver issues due to hepatitis risk factors, as well as common chemotherapy-related side effects such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is inoperable or has spread, and it's one of the specified types.
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Select...
I have gallbladder cancer.
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Select...
I have been diagnosed with esophageal adenocarcinoma.
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Select...
My cancer is HER2 positive based on previous tests.
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I am fully active or can carry out light work.
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I am part of the CRC patient group.
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I have been diagnosed with stomach cancer.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously received anti-HER2 therapies.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs) (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)
Secondary study objectives
Change in glomerular filtration rate (GFR) from baseline through 2 cycles of combination therapy (Cohorts 1A and 1B)
Confirmed objective response rate (cORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment (INV) (Cohort 2A)
Duration of response (DOR) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)
+11 more

Side effects data

From 2024 Phase 2 & 3 trial • 17 Patients • NCT04499924
50%
Diarrhoea
50%
Rash
38%
Alopecia
38%
Aspartate aminotransferase increased
38%
Constipation
38%
Pyrexia
25%
Stomatitis
25%
Weight decreased
25%
Abdominal pain
25%
Myalgia
25%
Epistaxis
25%
Hypertension
25%
Fatigue
25%
Nausea
25%
Alanine aminotransferase increased
25%
Anaemia
25%
Ejection fraction decreased
25%
Dermatitis acneiform
13%
Gastritis
13%
Dizziness
13%
Dyspnoea
13%
Respiratory failure
13%
Neutropenia
13%
Dyspepsia
13%
Vomiting
13%
Chills
13%
Localised oedema
13%
Skin infection
13%
Hyphaema
13%
Infusion related reaction
13%
Temperature intolerance
13%
Arthralgia
13%
Thrombocytopenia
13%
Eye pruritus
13%
Fall
13%
Acute kidney injury
13%
Rhinorrhoea
13%
Decreased appetite
13%
Skin laceration
13%
Enteritis
13%
Neck pain
13%
Myofascial pain syndrome
13%
Chromaturia
13%
Palmar-plantar erythrodysaesthesia syndrome
13%
Gastric haemorrhage
13%
Tympanic membrane perforation
13%
Anal fissure
13%
Anal haemorrhage
13%
Gastrooesophageal reflux disease
13%
Haemorrhoids
13%
Odynophagia
13%
Peripheral swelling
13%
Hyperbilirubinaemia
13%
COVID-19
13%
Rectal abscess
13%
Peripheral sensory neuropathy
13%
Cough
13%
Hypotension
13%
Intestinal sepsis
13%
Pneumonia
13%
Pneumothorax
13%
Night sweats
13%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paclitaxel 60 mg/m^2
Paclitaxel 80 mg/m^2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Cohort 2BExperimental Treatment5 Interventions
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.
Group II: Cohort 2AExperimental Treatment7 Interventions
Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Group III: Cohort 1GExperimental Treatment3 Interventions
Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Group IV: Cohort 1FExperimental Treatment5 Interventions
Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.
Group V: Cohort 1EExperimental Treatment6 Interventions
Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles
Group VI: Cohort 1DExperimental Treatment5 Interventions
Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days
Group VII: Cohort 1CExperimental Treatment4 Interventions
Tucatinib + trastuzumab + CAPOX given in 21-day cycles
Group VIII: Cohort 1BExperimental Treatment5 Interventions
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Group IX: Cohort 1AExperimental Treatment5 Interventions
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tucatinib
2021
Completed Phase 3
~810
trastuzumab
2002
Completed Phase 3
~1790
oxaliplatin
2002
Completed Phase 3
~6370
leucovorin
2005
Completed Phase 3
~1260
fluorouracil
1994
Completed Phase 3
~8440
capecitabine
2002
Completed Phase 3
~2360
pembrolizumab
2017
Completed Phase 3
~6440

Find a Location

Closest Location:Siteman Cancer Center - St Peters· Saint Peters, MO· 398 miles

Who is running the clinical trial?

Seagen, a wholly owned subsidiary of PfizerLead Sponsor
5 Previous Clinical Trials
1,436 Total Patients Enrolled
Seagen Inc.Lead Sponsor
211 Previous Clinical Trials
73,591 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,581 Previous Clinical Trials
47,975,435 Total Patients Enrolled
Christopher Lux, MD, PhDStudy DirectorSeagen Inc.
Medical MonitorStudy DirectorSeagen Inc.
1,678 Previous Clinical Trials
988,773 Total Patients Enrolled
JoAl Mayor, PharmD, BCOPStudy DirectorSeagen Inc.
5 Previous Clinical Trials
724 Total Patients Enrolled
Michelle Ubowski, PharmDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

Colorectal Cancer Research Study Groups: Cohort 1F, Cohort 1G, Cohort 1E, Cohort 1A, Cohort 2A, Cohort 1B, Cohort 1C, Cohort 1D, Cohort 2B
~8 spots leftby Mar 2026
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