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The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.
Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADCE-B05 | Experimental | Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADCE-B05 | Drug | Biological: Antibody-drug conjugate (ADC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the MTD/maximum administered dose of ADCE-B05 | Incidence of dose-limiting toxicities (DLTs) | From enrollment to the end of Phase 1a (Approximately 11 months after enrollment) |
| Assess the safety and tolerability of ADCE-B05 | Nature, incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | The maximum concentration (Cmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Time to maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Lybek Lind | Contact | +45 26461897 | charlotte.lind@adcendo.com | |
| Margaret McNaull | Contact | +44 7818457619 | margaret.mcnaull@adcendo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Recruiting | Springdale | Arkansas | 72762 | United States | |
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The time to maximum concentration (Tmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05 |
| Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Terminal half-life (T[1/2]) | The terminal half-life (T[1/2]) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Area under the concentration-time curve (AUC) | The area under the concentration-time curve (AUC) will be assessed to characterize PK profile of ADCE-B05 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Total antibody (TAb) | The total antibody will be assessed to characterize the Pharmacokinetic profile of ADCE-B05 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Free (de-conjugated) payload | The free (de-conjugated) payload will be assessed to characterize PK profile of ADCE-B05 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Objective response rate (ORR) | Objective response rate (ORR) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Duration of response (DOR) | Duration of response DOR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Progression-free survival (PFS) | Progression-free survival (PFS) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Disease Control Rate (DCR) | DCR will be assessed by investigator per RECIST v1.1 to evaluate preliminary antitumor activity | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Time to Response (TTR) | TTR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Yale University |
| Recruiting |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| University Of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Scientia Clinical Research | Recruiting | Randwick | New South Wales | 2031 | Australia |
| Southern Oncology Clinical Research Unit | Recruiting | Bedford Park | South Australia | 5042 | Australia |
| Monash Health | Not yet recruiting | Clayton | South Australia | 3165 | Australia |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |