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Clinical Trial Details

Geo Regions

Category

Other or Multiple Cancer Types

Tucatinib

A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
Phase 2
NCT04579380

Active Not-enrolling

Globe
Locations

United States, Belgium, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, United Kingdom

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Study design

Participant Group/Arm

EXPERIMENTAL: Tucatinib + Trastuzumab (+ Fulvestrant)

Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)

Intervention/Treatment

DRUG: tucatinib

300 mg orally twice daily

DRUG: trastuzumab

Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1

DRUG: fulvestrant

Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.

Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
  • Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
  • Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease
  • Disease progression during or after, or intolerance of, the most recent line of systemic therapy
  • Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following:
    • HER2 overexpression/amplification from fresh or archival tumor tissue or blood
    • Known activating HER2 mutations detected in fresh or archival tumor tissue or blo
  • Have measurable disease per RECIST v1.1 criteria according to investigator assessment
  • Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria
  • Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression.
  • Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab
  • Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer
  • History of exposure to a 360 mg/m² doxorubicin-equivalent or \>720 mg/m\^2 epirubicin-equivalent cumulative dose of anthracyclines
  • Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Exclusion criteria
  • Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression.
  • Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab
  • Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer
  • History of exposure to a 360 mg/m² doxorubicin-equivalent or \>720 mg/m\^2 epirubicin-equivalent cumulative dose of anthracyclines
  • Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Key dates

Study start date
  • January 2021
Estimated primary completion date
  • May 2025

Key endpoints

Primary Outcome Measures
Outcome Measure

Confirmed objective response rate (cORR) per investigator assessment

Measure Description

cORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time Frame

From start of treatment up to approximately 2 years

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Disease control rate (DCR) per investigator assessment

Measure Description

DCR is defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease according to RECIST v1.1

Time Frame

From start of treatment up to approximately 2 years

Outcome Measure

Duration of response (DOR) per investigator assessment

Measure Description

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 per RECIST v1.1 or death from any cause, whichever occurs first.

Time Frame

From start of treatment up to approximately 2 years

Outcome Measure

Progression-free survival (PFS) per investigator assessment

Measure Description

PFS is defined as the time from the date of treatment initiation to the date of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

Time Frame

From start of treatment up to approximately 2 years

Outcome Measure

Overall survival (OS)

Measure Description

OS is defined as the time from treatment initiation to death due to any cause.

Time Frame

From start of treatment up to approximately 4 years

Outcome Measure

Incidence of adverse events (AEs)

Measure Description

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.

Time Frame

From start of treatment up to approximately 2 years

Outcome Measure

Incidence of laboratory abnormalities

Measure Description

To be summarized using descriptive statistics.

Time Frame

From start of treatment up to approximately 2 years

Outcome Measure

Incidence of dose alterations

Measure Description

Time Frame

From start of treatment up to approximately 2 years

Outcome Measure

Maximum concentration (Cmax)

Measure Description

To be summarized using descriptive statistics.

Time Frame

Approximately 4 months, during first 6 cycles of treatment

Outcome Measure

Trough concentration (Ctrough)

Measure Description

To be summarized using descriptive statistics.

Time Frame

Approximately 4 months, during first 6 cycles of treatment

Secondary Outcome Measures table for Clinical Trial

Number of participants

217

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: None

This information is current as of November 18th 2023.
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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT04579380