An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Kathy Miller

Status and phase: Completed; Phase 1

Conditions: Metastatic Breast Cancer; Triple Negative Breast Cancer

Treatments: Drug: PTK7-ADC; Drug: Gedatolisib

Study type: Interventional

Funder types: Other

Identifiers

NCT03243331

IUSCC-0613

Details and patient eligibility

About

Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic Triple-negative Breast Cancer
• Willingness to undergo tumor biopsy
• Patients must have received at least 1 prior chemotherapy regimen for metastatic disease

Exclusion criteria

• Previous treatment with mTOR inhibitor
• Untreated brain metastases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Gedatolisb + PTK7-ADC

Experimental group

Treatment:

Drug: Gedatolisib

Drug: PTK7-ADC