Cervical Squamous Cell CarcinomaPhase 1/2NCT07169734
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
A Phase 1/2 study testing ALE.P03 in people with Cervical Squamous Cell Carcinoma and Squamous Non-small-cell Lung Cancer, run by Alentis Therapeutics AG at 41 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Squamous Cell Carcinoma, Squamous Non-small-cell Lung Cancer, Colorectal Cancer
- What is being tested?
- ALE.P03
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 41 sitesin 8 countries
- Study dates
- 26 Aug 2025to 4 Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
- Have documented radiological disease progression at study entry.
- Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
- 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:
Show all 12Show fewer
- Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
- Patients with actionable oncogenic drivers: received feasible targeted therapy.
- Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
- Measurable disease per RECIST 1.1, as determined by the site.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.
- Demonstrate adequate bone marrow and organ function as per the protocol.
Who cannot join
- SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
- Has received antineoplastic therapies prior to study intervention within specified time frame.
- Has rapidly progressing disease.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
- Has clinically significant gastrointestinal bleeding.
- Has an active infection requiring systemic treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.
Trial locations and contacts
41 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
41 sites in 8 countries
Spain12 sites, 12 recruiting
- Recruiting
Hospital HM Nou Delfos
Barcelona, 08023
Principal Investigator
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
Principal Investigator
- Recruiting
See outside Hospital Universitario Reina Sofia
Córdoba, 14004
Principal Investigator
- Recruiting
Virgen of Arrixaca University Clinical Hospital
El Palmar, 30120
Principal Investigator
- Recruiting
Ramón y Cajal Hospital
Madrid, 28034
Principal Investigator
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Principal Investigator
- Recruiting
HM Sanchinarro University Hospital
Madrid, 28050
Principal Investigator
- Recruiting
University Hospital Quironsalud Madrid
Madrid, 28223
Principal Investigator
- Recruiting
Hospital universitario virgen macarena
Seville, 41009
Principal Investigator
- Recruiting
San Juan de Reus University Hospital
Tarragona, 43204
Principal Investigator
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Principal Investigator
- Recruiting
La Fe University and Polytechnic Hospital
Valencia, 46026
Principal Investigator
United States9 sites, 9 recruiting
- Recruiting
The University of Chicago Medical Center - Oncology
Chicago, Illinois, 60637
Principal Investigator
Principal Investigator
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Principal Investigator
- Recruiting
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Principal Investigator
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Principal Investigator
- Recruiting
Norton Cancer Institute - Norton Healthcare Pavilion
Louisville, Kentucky, 40202
Principal Investigator
- Recruiting
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06510
Principal Investigator
- Recruiting
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, 85054
Principal Investigator
- Recruiting
Next Oncology-Oncology
San Antonio, Texas, 78229
Principal Investigator
Italy7 sites, 7 recruiting
- Recruiting
Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Principal Investigator
Principal Investigator
- Recruiting
Ospedale San Raffaele, IRCCS - Oncologia Medica
Milan, 20132
Principal Investigator
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Principal Investigator
- Recruiting
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, 20141
Principal Investigator
- Recruiting
Ravenna - Ospedale S. Maria delle Croci
Ravenna, 48121
Principal Investigator
Principal Investigator
- Recruiting
IRCCS Istituto Clinico Humanitas di Rozzano
Rossano, 20089
Principal Investigator
Principal Investigator
- Recruiting
Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica
Siena, 53100
Principal Investigator
Principal Investigator
France4 sites, 4 recruiting
- Recruiting
Centre Georges Francois Leclerc - Oncologie Medicale
Dijon, 21000
Principal Investigator
Principal Investigator
- Recruiting
CHU La Timone
Marseille, 13005
Principal Investigator
Principal Investigator
- Recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse, 31100
Principal Investigator
Principal Investigator
- Recruiting
Institut Gustave Roussy (IGR)
Villejuif, 94800
Principal Investigator
Netherlands3 sites, 3 recruiting
- Recruiting
The Netherlands Cancer Institute (NKI)
Amsterdam, 1066
Principal Investigator
Principal Investigator
- Recruiting
Radboudumc - Centrum voor Oncologie
Nijmegen, 6525
Principal Investigator
- Recruiting
Erasmus University Medical Center
Rotterdam, 3015
Principal Investigator
Principal Investigator
Taiwan3 sites, 3 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 100225
Principal Investigator
Principal Investigator
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Principal Investigator
Principal Investigator
- Recruiting
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology
Taoyuan, 33305
Principal Investigator
Principal Investigator
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital (NUH) - Medical Oncology
Singapore, 119074
Principal Investigator
- Recruiting
National Cancer Centre Singapore (NCCS)
Singapore, 168583
Principal Investigator
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)
Hong Kong, Hong-Kong
Principal Investigator
About this study
Official title: A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
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.
Read the detailed description
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.
- Conditions
- Cervical Squamous Cell Carcinoma, Squamous Non-small-cell Lung Cancer, Colorectal Cancer, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma
- Being tested
- ALE.P03
- Keywords
- Claudin-1 Targeted Antibody-Drug Conjugate, Monotherapy, First-in-Human, Recommended Phase 2 dose, Recommended dose for expansion
- Medical subject headings
- Colorectal Neoplasms, Cholangiocarcinoma, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALE.P03Drug
ALE.P03, will be administered by IV infusion according to the assigned arms.
ALE.P03Drug
ALE.P03, will be administered by IV infusion according to the assigned arms.
ALE.P03Drug
ALE.P03, will be administered by IV infusion according to the assigned arms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ALE.P03 |
| 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. Receives: Drug: ALE.P03 |
| 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. Receives: Drug: ALE.P03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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 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).
Measured: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
Secondary outcomes (19)
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)
Measured: 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)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start26 Aug 2025
- Primary completion5 Apr 2029 (estimated)
- Study completion4 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alentis Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169734
- Sponsor's protocol ID
- ALE.P03.01
- Other IDs
- 2025-521441-24-00, 2025
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
- ClinicalTrials.gov ID
- NCT07169734
- Acronym / sponsor ID
- ALE.P03.01
- Conditions
- Cervical Squamous Cell Carcinoma, Squamous Non-small-cell Lung Cancer, Colorectal Cancer, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma
- Keywords
- Claudin-1 Targeted Antibody-Drug Conjugate, Monotherapy, First-in-Human, Recommended Phase 2 dose, Recommended dose for expansion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Alentis Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 5 Apr 2029 (estimated)
- Study completion
- 4 Oct 2029 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Escalation- ALE.P03 | Experimental | Drug: ALE.P03Patients 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. |
| Phase I Dose Expansion- ALE.P03 | Experimental | Drug: ALE.P03Patients 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. |
| Phase II- ALE.P03 | Experimental | Drug: ALE.P03Patients will receive ALE.P03 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
- Have documented radiological disease progression at study entry.
- Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.
- Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
Key exclusion criteria (8 listed)
- SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
- Has received antineoplastic therapies prior to study intervention within specified time frame.
- Has rapidly progressing disease.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALE.P03ALE.P03, will be administered by IV infusion according to the assigned arms. | Drug | Phase I Dose Escalation- ALE.P03 |
| ALE.P03ALE.P03, will be administered by IV infusion according to the assigned arms. | Drug | Phase I Dose Expansion- ALE.P03 |
| ALE.P03ALE.P03, will be administered by IV infusion according to the assigned arms. | Drug | Phase II- ALE.P03 |
Primary outcome
Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I)
Time frame: Up to 28 days
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).
Number of Patients with Adverse Events (Phase I)
Time frame: From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years])
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).
Overall Response Rate (ORR) (Phase I)
Time frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
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)
Duration of Response (DoR) (Phase I)
Time frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
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).
Overall Response Rate (ORR) (Phase II)
Time frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
The ORR is assessed to assess anti-tumor activity of ALE.P03 (Phase II).
Duration of Response (DoR) (Phase II)
Time frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
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).
19 secondary outcomes
Number of Patients with Adverse Events (Phase I RDE and Phase II)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Blood Concentrations of Payload (Phase I and II)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Maximum Concentration (Cmax) (Phase I and II)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Minimum concentration (Cmin) (Phase I and II)
Time frame: 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)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The terminal elimination rate constant (KeL) (Phase I and II)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Terminal elimination half-life (t½) (Phase I and II)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Time of Maximum Concentration (tmax) (Phase I and II)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Average Concentration (Cavg) (Phase I and II)
Time frame: 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)
Time frame: 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)
Time frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALE.P03 in people with Cervical Squamous Cell Carcinoma and Squamous Non-small-cell Lung Cancer, run by Alentis Therapeutics AG at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Spain, United States, Italy, France, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alentis Clinical Trial Contact (+41782304288, patientinfo@alentis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I) (time frame: Up to 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.