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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04430738
Other study ID # SGNTUC-024
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 15, 2020
Est. completion date October 31, 2025

Study information

Verified date April 2024
Source Seagen Inc.
Contact Seagen Trial Information Support
Phone 8663337436
Email clinicaltrials@seagen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below: - Cohorts 1A, 1B, 1C, and 1D - CRC - Gastric adenocarcinoma - GEJ adenocarcinoma - Esophageal adenocarcinoma - Cholangiocarcinoma - Gallbladder carcinoma - Cohorts 1E, 1F, 1G, and 2A - Gastric adenocarcinoma - GEJ adenocarcinoma - Esophageal adenocarcinoma - Cohort 2B - CRC - Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G. - HER2+ disease, as determined by historic or local laboratory testing - Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator - Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator - Eastern Cooperative Oncology Group Performance Status score of 0 or 1. Exclusion Criteria: - History of known hypersensitivity to planned study treatment - Known to be positive for Hepatitis B or C - For Cohorts 2A and 2B: prior anti-HER2 therapies - For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Study Design


Intervention

Drug:
tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
fluorouracil
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
capecitabine
1000 mg/m^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
pembrolizumab
400 mg given by IV on day 1 of cycle 1, then every 6 weeks.

Locations

Country Name City State
Japan National Cancer Center Hospital Chuo-ku Other
Japan National Cancer Center Hospital East Kashiwa-shi Other
Japan St. Marianna University School of Medicine Kawasaki-shi Other
Japan The Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto-ku Other
Japan Aichi Cancer Center Nagoya-shi Other
Japan Osaka International Cancer Institute Osaka Other
Japan Kindai University Hospital Osakasayama-Shi Other
United States New Mexico Cancer Center Albuquerque New Mexico
United States University of Colorado Hospital / University of Colorado Aurora Colorado
United States Gabrail Cancer Center Research, LLC Canton Ohio
United States Levine Cancer Institute Charlotte North Carolina
United States University of Chicago Medical Center Chicago Illinois
United States Cleveland Clinic, The Cleveland Ohio
United States Duke University Medical Center Durham North Carolina
United States SCL Health Good Samaritan Medical Center Cancer Centers of Colorado Lafayette Colorado
United States Stanford Cancer Center / Blood and Marrow Transplant Program Palo Alto California
United States Mayo Clinic Arizona Phoenix Arizona
United States Mayo Clinic Rochester Rochester Minnesota
United States Washington University in St Louis Saint Louis Missouri
United States Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington Seattle Washington
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Johns Hopkins Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of renal dose-limiting toxicities (DLTs) (Cohorts 1A and 1B) Up to one month; 2 cycles after receiving all study treatment (each cycle is 14 days)
Primary Incidence of adverse events (AEs) (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B) An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Up to approximately 12 months
Primary Incidence of laboratory abnormalities (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B) Up to approximately 12 months
Primary Incidence of DLTs (Cohorts 1C, 1D, 1E, 1F, and 1G) Up to approximately 12 months
Primary Incidence of dose alterations (Cohort 1D) Up to approximately 12 months
Secondary Incidence of AEs (Cohorts 1A and 1B) An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Up to approximately 12 months
Secondary Incidence of laboratory abnormalities (Cohorts 1A and 1B) Up to approximately 12 months
Secondary Change in glomerular filtration rate (GFR) from baseline through 2 cycles of combination therapy (Cohorts 1A and 1B) To be summarized using descriptive statistics Up to approximately 6 weeks
Secondary Pharmacokinetic (PK) parameter of tucatinib - AUClast (Cohorts 1A and 1B) To be summarized using descriptive statistics Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
Secondary PK parameter of tucatinib - Cmax (Cohorts 1A and 1B) To be summarized using descriptive statistics Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
Secondary PK parameter of tucatinib - Ctrough (Cohorts 1A, 1B, 1C, 1E, 1F, and 1G) To be summarized using descriptive statistics Up to approximately 2.5 months; through predose of Cycle 6, Day 1
Secondary PK parameter of tucatinib - Tmax (Cohorts 1A and 1B) To be summarized using descriptive statistics Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
Secondary PK parameter of oxaliplatin - AUClast (Cohorts 1A and 1B) To be summarized using descriptive statistics Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
Secondary PK parameter of oxaliplatin - Cmax (Cohorts 1A and 1B) To be summarized using descriptive statistics Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
Secondary PK parameter of oxaliplatin - Tmax (Cohorts 1A and 1B) To be summarized using descriptive statistics Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
Secondary Confirmed objective response rate (cORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment (INV) (Cohort 2A) cORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) Up to approximately 2.5 years
Secondary Duration of response (DOR) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A) DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression or death from any cause, whichever occurs first. Up to approximately 2.5 years
Secondary Progression-free survival (PFS) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A) PFS is defined as the time from the date of treatment initiation to the date of disease progression or death from any cause, which occurs first. Up to approximately 2.5 years
Secondary Overall survival (OS) (Cohort 1C, 1E, 1F, 1G, and 2A) OS is defined as the time from treatment initiation to death due to any cause Up to approximately 2.5 years
Secondary Objective response rate (ORR) (Cohorts 1C, 1E, 1F, and 1G) ORR is defined as the proportion of subjects with confirmed CR or PR, according to RECIST v1.1. Up to approximately 2.5 years
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