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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516900-41-00 | EU Trial (CTIS) Number |
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The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADCE-D01 | Other | ADCE-D01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibody-drug conjugate (ADC) | Biological | ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the MTD/maximum administered dose and RP2DS of ADCE-D01. | Measuring incidence of dose-limiting toxicities (DLTs) | From enrollment to the end of Phase 1b (Approximately 18 months after enrollment) |
| Assess the safety and tolerability of ADCE-D01 | 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) | Time to maximum plasma concentration will be assessed to inform ADCE-D01 PK profile | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| ADCE-D01 time to Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| René Smrčka | Contact | +45 3144 0653 | rene.smrcka@adcendo.com | |
| Margaret McNaull | Contact | +44 7818 457619. | margaret.mcnaull@adcendo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Recruiting | Aurora | Colorado | 80208 | United States |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
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Time to Cmax (Tmax) will be assessed to characterize the ADCE-D01 PK profile
| Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| ADCE-D01 area under the concentration-time curve (AUC) | ADCE-D01 area under the concentration-time curve (AUC) will be assessed to characterize PK profile | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Evaluate ADCE-D01 objective response rate (ORR) | Objective response rate (ORR) per RECIST v1.1 by Investigator assessment | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| Evaluate ADCE-D01 duration of response (DOR) | Duration of response DOR, measured per RECIST v1.1 by Investigator assessment will be used to further characterize the durability of tumor response of ADCE-D01 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| ADCE-D01 progression-free survival (PFS) | Progression-free survival (PFS) assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity. | Throughout the trial duration, completion expected approximately 18 months from completed enrollmen |
| ADCE-D01 clinical benefit rate (CBR) | clinical benefit rate (CBR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| ADCE-D01 time to response (TTR) | time to response (TTR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01 | Throughout the trial duration, completion expected approximately 18 months from completed enrollment |
| University of Miami - Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| University Of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg | Recruiting | Leuven | 3000 | Belgium |
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| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
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| Universitätsklinikum Essen West German Tumor Center | Recruiting | Essen | D-45147 | Germany |
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| Royal Marsden | Not yet recruiting | London | United Kingdom |
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| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |