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Chemotherapy

Tucatinib + Trastuzumab + Chemotherapy for Gastrointestinal Cancer

Phase 1 & 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

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.

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.

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.

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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I have gallbladder cancer.

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I have been diagnosed with esophageal adenocarcinoma.

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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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2.5 years

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 2022 Phase 2 trial • 612 Patients • NCT02614794

82%

Diarrhoea

66%

Palmar-plantar erythrodysaesthesia syndrome

60%

Nausea

48%

Fatigue

38%

Vomiting

27%

Decreased appetite

26%

Stomatitis

24%

Headache

23%

Aspartate aminotransferase increased

22%

Anaemia

22%

Alanine aminotransferase increased

20%

Blood bilirubin increased

20%

Arthralgia

18%

Hypokalaemia

17%

Constipation

17%

Cough

16%

Abdominal pain

16%

Blood creatinine increased

15%

Weight decreased

14%

Back pain

13%

Epistaxis

13%

Pain in extremity

13%

Dizziness

13%

Peripheral sensory neuropathy

13%

Dyspnoea

11%

Muscle spasms

11%

Dry skin

11%

Dyspepsia

11%

Upper respiratory tract infection

11%

Urinary tract infection

11%

Oedema peripheral

10%

Pruritus

10%

Insomnia

Neutropenia

Hypomagnesaemia

Abdominal pain upper

Dehydration

Myalgia

Asthenia

Dysgeusia

Oropharyngeal pain

Skin hyperpigmentation

Thrombocytopenia

Rash maculo-papular

Hypophosphataemia

Blood alkaline phosphatase increased

Abdominal distension

Hyperbilirubinaemia

Fall

Rhinorrhoea

Paraesthesia

Dry eye

Hyperglycaemia

Gastrooesophageal reflux disease

Influenza like illness

Pyrexia

Paronychia

Alopecia

White blood cell count decreased

Muscular weakness

Dry mouth

Neutrophil count decreased

Platelet count decreased

Hypertension

Nasopharyngitis

Seizure

Pneumonia

Influenza

Cholecystitis

Sepsis

Ejection fraction decreased

Syncope

Pleural effusion

Pulmonary embolism

Cardiac failure

Gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Tuc+Cap+Tra

Pbo+Cap+Tra

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