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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTAC-0001 and pembrolizumab | Experimental | TTAC-0001 and pembrolizumab combination therapy will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTAC-0001 and pembrolizumab combination | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities | The frequency and percentage of DLT will be presented by dose level | During the first cycle (every cycle is 21 days) of treatment |
| Adverse events | The frequency and percentage of AEs will be presented by dose level | 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 |
| Immunogenicity | Presence anti-drug antibody (ADA) will be listed | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | complete response (CR) or partial response (PR) by RECIST criteria | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters - Cmax | Maximum concentration of drug by dose level | 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 |
| Pharmacokinetic parameters - Cmin |
Inclusion Criteria:
(1) Hematologic tests
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia | ||
| Hollywood Private Hospital |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C570591 | olinvacimab |
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|
complete response (CR), partial response (PR) or stable disease (SD) by RECIST criteria |
| 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 | Period from the date of the drug administration to the disease progression time point | 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 | Period from the date of the drug administration to the patient's death | 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 |
Minimum concentration of drug by dose level |
| 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 |
| Pharmacokinetic parameters - AUC0-t | Area under the curve from baseline to each timepoint by dose level | 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 |
| Pharmacokinetic parameters - Tmax | Time of Cmax by dose level | 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 |
| Pharmacokinetic parameters - CL | Clearance by dose level | FFrom 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 |
| Pharmacokinetic parameters - Vd | Volume of distribution by dose level | 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 |
| Pharmacokinetic parameters - Ke | Elimination rate constant by dose level | 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 |
| Pharmacokinetic parameters - T½ | Half-life by dose level | 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 |
| Change in concentration of serum angiogenic factor or receptor | VEGF, placental growth factor [PLGF], soluble vascular endothelial growth factor receptor [sVEGFR]-2, sVEGFR-1, etc. | 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 |
| PD-L1, VEGFR-2 expression level | PD-L1, VEGFR-2 expression level in tumour environment such as tumour, tumour vessel and parenchymal tissue | 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 |
| Nedlands |
| Western Australia |
| 6009 |
| Australia |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |