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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521441-24-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.
This Study has a Phase I ALE.P03 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P03 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Dose Escalation- ALE.P03 | Experimental | Patients will receive ALE.P03 as monotherapy via intravenous infusion. The ALE.P03 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended dose for expansion (RDE) is determined in Phase I dose escalation part of the study. |
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| Phase I Dose Expansion- ALE.P03 | Experimental | Patients will receive ALE.P03 as monotherapy via intravenous infusion. The safe recommended doses of ALE.P03 will be given in Phase I dose expansion part of the study to identify recommended Phase II dose (RP2D) for Phase II. |
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| Phase II- ALE.P03 | Experimental | Patients will receive ALE.P03 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALE.P03 | Drug | ALE.P03, will be administered by IV infusion according to the assigned arms. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I) | DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE). | Up to 28 days |
| Number of Patients with Adverse Events (Phase I) | Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE). | From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years]) |
| Overall Response Rate (ORR) (Phase I) | The ORR is the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) This is assessed to establish RP2D for ALE.P03 (Phase I RDE) | From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years) |
| Duration of Response (DoR) (Phase I) | The DoR is defined for patients achieving a CR or PR as per Investigator review according to RECIST 1.1 to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P03 (Phase I RDE). | From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years) |
| Overall Response Rate (ORR) (Phase II) | The ORR is assessed to assess anti-tumor activity of ALE.P03 (Phase II). | From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Adverse Events (Phase I RDE and Phase II) | Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I RDE and Phase II) | From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years] |
| Disease control rate (DCR) (Phase I and II) |
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Inclusion Criteria:
Phase I Dose Escalation:
- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.
Phase I RDE and Phase II:
Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alentis Clinical Trial Contact | Contact | +41782304288 | patientinfo@alentis.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Comprehensive Cancer Center | Recruiting | Phoenix | Arizona | 85054 | United States |
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For Phase I recommended dose for expansion (RDE) part of the study, patients will be randomized in 1:1 ratio to identify the recommended Phase II dose (RP2D) for Phase II.
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| ALE.P03 | Drug | ALE.P03, will be administered by IV infusion according to the assigned arms. |
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| ALE.P03 | Drug | ALE.P03, will be administered by IV infusion according to the assigned arms. |
|
| Duration of Response (DoR) (Phase II) |
The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to assess anti-tumor activity of ALE.P03 (Phase II). |
| From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years) |
The DCR is defined as the proportion of patients with a BOR of CR or PR or stable disease (SD) per Investigator review according to RECIST 1.1 at or prior to initiation of the use of new anti-cancer therapy. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P03 (Phase I and II). |
| From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years) |
| Median Progression-Free Survival (PFS) rate at 6 and 12 Months (Phase I and II) | The PFS is defined as time from first study treatment to a documented disease progression according to RECIST 1.1, as determined by the Investigator, or death due to any cause, whichever occurs earlier. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P03 (Phase I and II). | At 6 and 12 months after initiation of ALE.P03 treatment |
| Median Overall Survival (OS) rate at 6, 12, and 24 Months (Phase I and II) | The OS is defined as time from first study treatment to death due to any cause. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P03 (Phase I and II). | At 6, 12, and 24 months after initiation of ALE.P03 treatment |
| Blood Concentration of ALE.P03 Antibody-drug Conjugate (ADC) (Phase I and II) | Concentrations of ALE.P03 ADC in blood will be measured at each scheduled time point per arms. | Phase I and II: From Day 1 until at end of treatment visit (EoT) (Up to 4 years) |
| Blood Concentrations of Total Antibody (Phase I and II) | Concentrations of total antibody in blood will be measured at each scheduled time point per arms. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Blood Concentrations of Payload (Phase I and II) | Concentrations of payload in blood will be measured at each scheduled time point per arms. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Area under the concentration-time curve over the dosing interval (AUCtau) (Phase I and II) | The AUCtau of ALE.P03 will be measured to assess the pharmacokinetic (PK) profile of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUClast) (Phase I and II) | The AUClast of ALE.P03 will be measured to assess the PK profile of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUCinf) (Phase I and II) | The AUCinf of ALE.P03 will be measured to assess the PK profile of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Maximum Concentration (Cmax) (Phase I and II) | The Cmax of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined directly from the concentration-time profile. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Minimum concentration (Cmin) (Phase I and II) | The Cmin of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined directly from the concentration-time profile. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Concentration at the end of a dosing interval (Ctrough) (Phase I and II) | The Ctrough of ALE.P03 will be measured to assess the PK profile of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| The terminal elimination rate constant (KeL) (Phase I and II) | The KeL of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined by selection of at least three data points on the terminal phase of the concentration-time curve. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Terminal elimination half-life (t½) (Phase I and II) | The t½ of ALE.P03 will be measured to assess the PK profile of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Time of Maximum Concentration (tmax) (Phase I and II) | The tmax of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined directly from the concentration-time profile. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Average Concentration (Cavg) (Phase I and II) | The Cavg of ALE.P03 will be measured to assess the PK profile of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Number of Patients with Presence of anti-ALE.P03 Antibodies (Phase I and II) | Presence of anti-ALE.P03 Antibodies will be assessed to evaluate the immunogenicity of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| Number of Patients with Positive anti-ALE.P03 Antibodies (Phase I and II) | Presence of anti-ALE.P03 Antibodies (positive/negative) will be assessed to evaluate the immunogenicity of ALE.P03. | Phase I and II: From Day 1 until at EoT (Up to 4 years) |
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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| Yale Comprehensive Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
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| The University of Chicago Medical Center - Oncology | Recruiting | Chicago | Illinois | 60637 | United States |
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| Norton Cancer Institute - Norton Healthcare Pavilion | Recruiting | Louisville | Kentucky | 40202 | United States |
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| John Theurer Cancer Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Next Oncology-Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
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| NEXT Oncology Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Centre Georges Francois Leclerc - Oncologie Medicale | Recruiting | Dijon | 21000 | France |
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| CHU La Timone | Recruiting | Marseille | 13005 | France |
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| Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole) | Recruiting | Toulouse | 31100 | France |
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| Institut Gustave Roussy (IGR) | Recruiting | Villejuif | 94800 | France |
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| Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) | Recruiting | Hong Kong | Hong-Kong | Hong Kong |
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| Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
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| Ospedale San Raffaele, IRCCS - Oncologia Medica | Recruiting | Milan | 20132 | Italy |
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| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
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| IEO - Istituto Europeo di Oncologia, IRCCS | Recruiting | Milan | 20141 | Italy |
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| Ravenna - Ospedale S. Maria delle Croci | Recruiting | Ravenna | 48121 | Italy |
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| IRCCS Istituto Clinico Humanitas di Rozzano | Recruiting | Rossano | 20089 | Italy |
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| Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica | Recruiting | Siena | 53100 | Italy |
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| The Netherlands Cancer Institute (NKI) | Recruiting | Amsterdam | 1066 | Netherlands |
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| Radboudumc - Centrum voor Oncologie | Recruiting | Nijmegen | 6525 | Netherlands |
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| Erasmus University Medical Center | Recruiting | Rotterdam | 3015 | Netherlands |
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| National University Hospital (NUH) - Medical Oncology | Recruiting | Singapore | 119074 | Singapore |
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| National Cancer Centre Singapore (NCCS) | Recruiting | Singapore | 168583 | Singapore |
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| Hospital HM Nou Delfos | Recruiting | Barcelona | 08023 | Spain |
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| Vall d'Hebron University Hospital | Recruiting | Barcelona | 08035 | Spain |
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| See outside Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
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| Virgen of Arrixaca University Clinical Hospital | Recruiting | El Palmar | 30120 | Spain |
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| Ramón y Cajal Hospital | Recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
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| HM Sanchinarro University Hospital | Recruiting | Madrid | 28050 | Spain |
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| University Hospital Quironsalud Madrid | Recruiting | Madrid | 28223 | Spain |
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| Hospital universitario virgen macarena | Recruiting | Seville | 41009 | Spain |
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| San Juan de Reus University Hospital | Recruiting | Tarragona | 43204 | Spain |
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| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
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| La Fe University and Polytechnic Hospital | Recruiting | Valencia | 46026 | Spain |
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| National Cheng Kung University Hospital | Recruiting | Tainan | 100225 | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | 100225 | Taiwan |
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| Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology | Recruiting | Taoyuan | 33305 | Taiwan |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D018281 | Cholangiocarcinoma |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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