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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515459-39-00 | 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.P02 monotherapy in adult patients with selected squamous solid tumors.
This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 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.P02 | Experimental | Patients will receive ALE.P02 as monotherapy via intravenous infusion. The ALE.P02 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.P02 | Experimental | Patients will receive ALE.P02 as monotherapy via intravenous infusion. The safe recommended dose of ALE.P02 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.P02 | Experimental | Patients will receive ALE.P02 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.P02 | Drug | ALE.P02, 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) | DLTs as defines in the protocol will be assessed to evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE). | Up to 28 days |
| Number of Patients with Adverse Events | Adverse events will be assessed to evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE). | Screening (day -28 to day -1) up to Safety follow-up (30 ± 5 days post last dose [Up to 3.5 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.P02 (Phase I RDE) | From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years) |
| Duration of Response (DoR) (Phase I) | The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR per Investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P02 (Phase I RDE). | From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years) |
| Overall Response Rate (ORR) (Phase II) | The ORR is assessed to assess anti-tumor activity of ALE.P02 (Phase II). | From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) (Phase I and II) | The DCR is defined as the proportion of patients with a confirmed 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.P02 (Phase I and II). | From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years) |
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Inclusion Criteria:
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 Foundation for Medical Education and Research - Mayo Cl | Recruiting | Scottsdale | Arizona | 85259 | United States | |
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| Duration of Response (DoR) (Phase II) | The DoR is assessed to assess anti-tumor activity of ALE.P02 (Phase II). | From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years) |
| Median Progression-Free Survival (PFS) 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.P02 (Phase I and II). | At 6 and 12 months after initiation of ALE.P02 treatment |
| Median Overall Survival (OS) 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.P02 (Phase I and II). | At 6, 12, and 24 months after initiation of ALE.P02 treatment |
| Blood Concentration of ALE.P02 Antibody-drug Conjugate (ADC) | Concentrations of ALE.P02 ADC in blood will be measured at each scheduled time point per arms to assess the pharmacokinetic (PK) profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at end of treatment visit (EoT) (Up to 3.5 years) |
| Blood Concentration of Total Antibody | Total antibody in blood will be measured at each scheduled time point per arms to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Blood Concentrations of Payload | Concentrations of payload in blood will be measured at each scheduled time point per arms to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Area under the concentration-time curve over the dosing interval (AUCtau) | The AUCtau of ALE.P02 will be measured to assess the pharmacokinetic (PK) profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUClast) | The AUClast of ALE.P02 will be measured to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUCinf) | The AUCinf of ALE.P02 will be measured to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Maximum Concentration (Cmax) | The Cmax of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined directly from the concentration-time profile. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Minimum concentration (Cmin) | The Cmin of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined directly from the concentration-time profile. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Concentration at the end of a Dosing Interval (Ctrough) | The Ctrough of ALE.P02 will be measured to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| The terminal elimination rate constant (KeL) | The KeL of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined by selection of at least three data points on the terminal phase of the concentration-time curve. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Terminal elimination half-life (t½) | The t½ of ALE.P02 will be measured to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Time of Maximum Concentration (tmax) | The tmax of ALE.P02 will be measured to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Average Concentration (Cavg) | The Cavg of ALE.P02 will be measured to assess the PK profile of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Number of Patients with Presence of anti-ALE.P02 Antibodies | Presence of anti-ALE.P02 Antibodies will be assessed to evaluate the immunogenicity of ALE.P02. | Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years) |
| Providence Medical Foundation |
| Recruiting |
| Fullerton |
| California |
| 92835 |
| United States |
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
| Yale Comprehensive Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
| The University of Chicago Medical Center - Oncology | Recruiting | Chicago | Illinois | 60637 | United States |
| Norton Cancer Institue Downtown | Recruiting | Louisville | Kentucky | 40202 | United States |
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| NEXT Oncology Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Institut Bergonie | Recruiting | Bordeaux | 33000 | France |
| Centre Georges Francois Leclerc - Oncologie Medicale | Recruiting | Dijon | 21079 | France |
| CHRU De Lille- Hôpital Claude Huriez - Medical Oncology | Recruiting | Lille | 59000 | France |
| AP-HM Hôpital de La Timone CEPCM | Recruiting | Marseille | 13005 | France |
| Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole | Recruiting | Toulouse | 31100 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94800 | France |
| Chinese University of Hong Kong - Prince of Wales Hospital | Recruiting | Shatin | N.T. | Hong Kong |
| Istituto Clinico Humanitas | Recruiting | Milan | 20089 | Italy |
| Ospedale San Raffaele, IRCCS | Recruiting | Milan | 20132 | Italy |
| Istituto Nazionale del Tumori, Fondazione IRCCS | Recruiting | Milan | 20133 | Italy |
| IEO - Istituto Europeo di Oncologia, IRCCS | Recruiting | Milan | 20141 | Italy |
| Ospedale Santa Maria delle Croci di Ravenna Oncologia | Recruiting | Ravenna | 48121 | Italy |
| PU A. Gemelli, Universita Cattolica del Sacro Cuore | Recruiting | Roma | Italy |
| Centro Ricerche Cliniche Verona | Recruiting | Verona | Italy |
| National University Cancer Institue | Recruiting | Singapore | South West | 11907 | Singapore |
| National Cancer Centre Singapore | Recruiting | Singapore | South West | 168583 | Singapore |
| National Cancer Center | Recruiting | Goyang-si | 10408 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center - Oncology | Recruiting | Seoul | 5505 | South Korea |
| START Madrid- Centro Integral Oncologico Clara Campal | Recruiting | PAU de Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Quironsalud Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| NEXT Oncology Barcelona | Recruiting | Barcelona | 08023 | Spain |
| Hospital Universitari Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| START Hospital HM Nou Delfos | Recruiting | Barcelona | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario Virgen De La Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen De La Macarena | Recruiting | Seville | 41009 | Spain |
| Hospital Universitario Y Politécnico La Fe | Recruiting | Valencia | 46026 | Spain |
| Changhua Christian Medical Foundation Changhua Christian Hospital | Recruiting | Changhua | 50006 | Taiwan |
| Changhua Christian Medical Foundation Changhua Christian Hospital | Recruiting | Changhua | 500209 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 100225 | Taiwan |
| Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital | Recruiting | Taipei | 231020 | Taiwan |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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