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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002935-32 | EudraCT Number |
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The study was prematurely terminated because the emerging benefit:risk ratio did not justify continuing dosing patients.
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This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study will establish the safety and tolerability profile of RO6927005 and will be conducted in two parts.
In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single patient cohorts will be used to investigate increasing doses until a first dose-limiting toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related reactions), whichever comes first. At least 3 patients will be enrolled in each cohort thereafter, which, if required, can be expanded with additional patients. Part B of the study will consist of a multiple ascending dose phase (multiple patients cohorts - >/= 3 patients) followed by an extension phase of RO6927005 given in combination with gemcitabine/nab-paclitaxel.
Preliminary clinical activity will be explored throughout the study. Patients will be treated until disease progression and/or lack of clinical benefit, unacceptable toxicities, withdrawal from treatment for other reasons, death, pregnancy or termination of the study by the Sponsor, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A MAD Phase RO6927005 Monotherapy | Experimental | RO6927005 given as a single agent in participants with tumors known to be mesothelin expressing and with mesothelin-positive tumors. MAD = multiple ascending dose. |
|
| Part A Extension Phase Group 1 | Experimental | RO6927005 given as a single agent in participants with mesothelin-positive refractory/recurrent solid tumors, other than malignant pleural mesothelioma (MPM) and pancreatic ductal adenocarcinoma (PDA) |
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| Part A Extension Phase Group 2 | Experimental | RO6927005 given as a single agent in participants with mesothelin-positive metastatic and/or advanced PDA |
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| Part B MAD Phase | Experimental | RO6927005 with gemcitabine/nab-paclitaxel in participants with mesothelin-positive metastatic and/or advanced PDA |
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| Part B Extension Phase | Experimental | RO6927005 with gemcitabine/nab-paclitaxel in participants with PDA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO6927005 | Drug | RO6927005 administered intravenously on Days 1, 3, and 5 of each 21-day treatment cycle (QOD x 3). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of dose-limiting toxicities, adverse events, laboratory abnormalities; incidence of anti-drug antibodies, abnormal findings on physical examination, infusion-related reactions (composite outcome measure) | Until disease progression, unacceptable toxicities, withdrawal for other reasons, death, or termination of the study by the Sponsor, whichever comes first, up to 2 years 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of RO6927005 monotherapy based on free and total plasma RO6927005 concentrations over time (area under the curve) | Up to 2 years 8 months | |
| Pharmacokinetic profile of RO6927005 in combination with gemcitabine/nab-paclitaxel, based on free and total plasma RO6927005 concentrations over time (area under the curve) |
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Inclusion Criteria:
Inclusion Criteria Part A: MAD
Inclusion Criteria Part A: MAD and Extension Phase (Group 1 and Group 2)
Inclusion Criteria Part B
Exclusion Criteria:
Exclusion Criteria (Part B):
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bethesda | Maryland | 20889-0001 | United States | |||
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| RO6927005 | Drug | RO6927005 administered intravenously on Days 1, 3, and 5 of each 28-day treatment cycle (QOD x 3). |
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| gemcitabine | Drug | gemcitabine administered according to local label on Days 1, 8, and 15 of each 28-day cycle. |
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| nab-paclitaxel | Drug | nab-paclitaxel administered according to the local label on Days 1, 8, and 15 of each 28-day cycle. |
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| Up to 2 years 8 months |
| Efficacy: objective response rate, disease control rate, duration of response, progression-free survival, overall survival (composite outcome measure) | Up to 2 years 8 months |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| København Ø | 2100 | Denmark |
| Bordeaux | 33076 | France |
| Toulouse | 31059 | France |
| Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000597116 | LMB-100 |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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