A Phase 1b, Open-Label, Safety and Tolerability Study of TTAC-0001 in Combination With Pembrolizumab in Patients With Metastatic Triple-Negative Breast Cancer

PharmAbcine2 sites in 1 country11 target enrollmentJanuary 3, 2019

ConditionsTriple Negative Breast Cancer

InterventionsTTAC-0001 and pembrolizumab combination

DrugsTTAC-0001 and pembrolizumab combination

Overview

Phase: Phase 1
Intervention: TTAC-0001 and pembrolizumab combination
Conditions: Triple Negative Breast Cancer
Sponsor: PharmAbcine
Enrollment: 11
Locations: 2
Primary Endpoint: Dose limiting toxicities
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 1b, open-Label clinical trial to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of TTAC-0001 administered in combination with pembrolizumab in patients with metastatic triple-negative breast cancer.

Registry

clinicaltrials.gov

Start Date

January 3, 2019

End Date

October 26, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

PharmAbcine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female and male patients ≥18 years old
•Histologically proven metastatic breast carcinoma with triple negative receptor status (Estrogen receptor, Progesterone receptor and human epidermal growth factor receptor 2 \[HER2\] negative) by IHC and Fluorescence in situ hybridization (FISH) according to ASCO-CAP guideline
•At least one confirmed measurable lesion by RECIST 1.1 criteria
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•A person who satisfies the following criteria in hematologic, renal, and hepatic function tests performed within 7 days prior to screening:
•(1) Hematologic tests
•Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
•Platelets ≥ 100 x 109/L
•Haemoglobin ≥ 9.0 g/dL (2) Blood coagulation tests
•Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (UNL)

Exclusion Criteria

•Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. (Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) controlled by curative therapy are not excluded)
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
•Has a history of (non-infectious) pneumonitis/interstitial lung diseases that required steroids or current pneumonitis/interstitial lung disease.
•Has an active infection requiring systemic therapy
•Uncontrolled hypertension (systolic blood pressure \[SBP\]\> 150 or diastolic blood pressure \[DBP\]\> 90 mmHg)
•Uncontrolled seizures
•Class III or IV heart failure by New York Heart Association (NYHA) classification
•Has oxygen-dependent chronic disease
•Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion
•History of abdominal fistula or gastrointestinal perforation within 6 months prior to start of study drug

Arms & Interventions

TTAC-0001 and pembrolizumab

TTAC-0001 and pembrolizumab combination therapy will be administered.

Intervention: TTAC-0001 and pembrolizumab combination

Outcomes

Primary Outcomes

Dose limiting toxicities

Time Frame: During the first cycle (every cycle is 21 days) of treatment

The frequency and percentage of DLT will be presented by dose level

Adverse events

Time Frame: From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

The frequency and percentage of AEs will be presented by dose level

Immunogenicity

Time Frame: From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Presence anti-drug antibody (ADA) will be listed

Secondary Outcomes

Overall response rate(At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years (every cycle is 21 days)])
Disease control rate(At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years (every cycle is 21 days))
Progression free survival(From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
Overall survival(From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)