Clinical trial • Phase II • Oncology
AL8326 for Small cell lung cancer
Phase II trial of AL8326 for Small cell lung cancer. Randomised, open-label, adaptive. 100 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-02-2024
- First CTIS Authorization Date
- 19-06-2024
Trial design
Randomised, open-label, adaptive Phase II trial across 9 sites in Italy, Spain.
- Randomised
- Yes
- Open Label
- Yes
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 100
Stratification factors
- Prior line of treatment (=2nd vs >2nd line)
Eligibility
Recruits 100 adults.
Inclusion criteria
- {"criterion_text":"- 1. Male or female, 18 years of age or older.\n- 2. ECOG performance status of 0 or 1.\n- 3. Histologically or cytologically confirmed SCLC.\n- 4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1.\n- 5. Have a life expectancy of at least 3 months."}
Exclusion criteria
- {"criterion_text":"- Serious, non-healing wound, ulcer or bone fracture\n- Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment\n- Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels\n- Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease\n- Hemoptysis within 3 months prior to enrollment\n- Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it."}
Endpoints
Primary endpoints
- {"endpoint_text":"- OBD and ORR for all dosing groups and OBD group plus expansion cohort","definition_or_measurement_approach":"To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group; Objective Response Rate (ORR) for dosing groups and OBD group plus expansion cohort."}
Secondary endpoints
- {"endpoint_text":"- DOR for OBD group plus expansion cohort\n- PFS\n- Pharmacokinetic endpoints such as Cmax, AUC and other typic PK parameters\n- PK/PD/Efficacy/Safety relationship\n- Possible biomarker identification","definition_or_measurement_approach":"Duration of Response (DOR) for OBD group and expansion cohort; Progression-Free Survival (PFS); PK endpoints including Cmax and AUC and other standard PK parameters; characterization of PK/PD/Efficacy/Safety relationships; exploratory biomarker identification."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 132
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 30
Italy
- Earliest CTIS Part Ii Submission Date
- 16-05-2024
- Latest Decision Or Authorization Date
- 21-06-2024
- Processing Time Days
- 36
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Fondazione Policlinico Universitario Campus Bio-Medico
- Department Name
- Dipartimento di Oncologia Medica
- Principal Investigator Name
- Giuseppe Tonini
- Principal Investigator Email
- g.tonini@policlinicocampus.it
- Contact Person Name
- Giuseppe Tonini
- Contact Person Email
- g.tonini@policlinicocampus.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Struttura Complessa di Medicina Oncologica I
- Principal Investigator Name
- Giuseppe Lo Russo
- Principal Investigator Email
- giuseppe.lorusso@istitutotumori.mi.it
- Contact Person Name
- Giuseppe Lo Russo
- Contact Person Email
- giuseppe.lorusso@istitutotumori.mi.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncologia Medica 2
- Principal Investigator Name
- Valentina Guarneri
- Principal Investigator Email
- valentina.guarneri@unipd.it
- Contact Person Name
- Valentina Guarneri
- Contact Person Email
- valentina.guarneri@unipd.it
Spain
- Earliest CTIS Part Ii Submission Date
- 10-05-2024
- Latest Decision Or Authorization Date
- 19-06-2024
- Processing Time Days
- 40
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Noemi Reguart
- Principal Investigator Email
- nreguart@clinic.cat
- Contact Person Name
- Noemi Reguart
- Contact Person Email
- nreguart@clinic.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Medical Oncology
- Principal Investigator Name
- Francisco de Asis Aparisi Aparisi
- Principal Investigator Email
- francisco_aparisi@iislafe.es
- Contact Person Name
- Francisco de Asis Aparisi Aparisi
- Contact Person Email
- francisco_aparisi@iislafe.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology
- Principal Investigator Name
- María Eugenia Olmedo Garcia
- Principal Investigator Email
- maruolmedogarcia@hotmail.com
- Contact Person Name
- María Eugenia Olmedo Garcia
- Contact Person Email
- maruolmedogarcia@hotmail.com
- Site Name
- Vall D'hebron Institut De Recerca
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pedro Filipe Simoes da Rocha
- Principal Investigator Email
- pedrorocha@vhio.net
- Contact Person Name
- Pedro Filipe Simoes da Rocha
- Contact Person Email
- pedrorocha@vhio.net
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Rosario García Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- Maria Rosario García Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
Sponsor
Primary sponsor
- Full Name
- Advenchen Pharmaceuticals LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Third parties
- {"country":"United States","full_name":"Tempus Labs Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Sofpromed Investigacion Clinica S.L.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- AL8326
- Active Substance
- AL8326
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Starting Dose
- 40 mg
- Dose Levels
- 40 mg | 60 mg | 80 mg
- Frequency
- Daily
- Maximum Dose
- 80 mg
- Dose Escalation Increase
- Initial: 40 mg; subsequent: 60 mg, 80 mg
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