Clinical trial • Phase II • Oncology

AL8326 for Small cell lung cancer | Non-small cell lung cancer | Renal cell carcinoma

Phase II trial of AL8326 for Small cell lung cancer | Non-small cell lung cancer | Renal cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small cell lung cancer | Non-small cell lung cancer | Renal cell carcinoma
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-10-2024
First CTIS Authorization Date
10-02-2025

Trial design

Randomised, open-label, al8326 40 mg daily versus al8326 60 mg daily (randomized 1:1 in phase 2 obd). no external placebo or active comparator specified.-controlled, adaptive Phase II trial in Spain, Italy.

Randomised
Yes
Open Label
Yes
Comparator
AL8326 40 mg daily versus AL8326 60 mg daily (randomized 1:1 in Phase 2 OBD). No external placebo or active comparator specified.
Adaptive
True, elements include OBD (Optimal Biological Dose) finding with randomized dosing cohorts, dose selection and expansion cohorts after OBD determination; dose level 80 mg was stopped for intolerability; ability to expand cohorts (additional 6-12 patients) based on interim OBD results.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
80

Stratification factors

  • =2nd or >2nd line treatment (yes vs no)

Eligibility

Recruits 80 isVulnerablePopulationSelected=true. Participants are adults (18 years and older); informed consent required. Subject information and informed consent forms are provided (documents listed: L1_SIS and ICF adults and other subject information material in published documents). No procedures for assent or minor consent described..

Vulnerable Population
isVulnerablePopulationSelected=true. Participants are adults (18 years and older); informed consent required. Subject information and informed consent forms are provided (documents listed: L1_SIS and ICF adults and other subject information material in published documents). No procedures for assent or minor consent described.

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 or advanced (not amenable to curativesurgery) non - small cell lung cancer (NSCLC), or advanced /metastatic renal cellcarcinoma (RCC, histopathological confirmed clear cell renal cell cancer or with acomponent of clear cell), which has received at least first - line standard care therapy andnow requires second, third, or fourth -line therapy).\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 (for SCLC and NSCLC); have a lifeexpectancy of ≥6 months (for RCC)."}

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 for SCLC cohort. ORR for NSCLC and RCC cohort","definition_or_measurement_approach":"OBD: determination based on efficacy and safety of each dosing group. ORR: objective response rate assessed (measurability requirement per RECIST 1.1)."}

Secondary endpoints

  • {"endpoint_text":"-DOR and PFS for SCLC OBD group plus expansion cohort; NSCLC and RCC cohortgroup; ; Pharmacokinetic endpoints such as Cmax, AUC and other typic PK parameters; and PK/PD/Efficacy/Safety relationship for SCLC.","definition_or_measurement_approach":"Duration of Response (DOR) and Progression Free Survival (PFS) measured per study schedule; pharmacokinetic endpoints include Cmax, AUC and other standard PK parameters; PK/PD and exposure-response analyses to characterize relationships with efficacy and safety."}

Other endpoints

  • {"endpoint_text":"-Biomarker exploratory study.","definition_or_measurement_approach":"Exploratory biomarker analyses as described in protocol (biomarker study to explore associations with PK/PD/efficacy/safety)."}

Recruitment

Planned Sample Size
80
Recruitment Window Months
132
Consent Approach
Informed consent is required from adult participants. Subject information and informed consent documents are provided (documents: L1_SIS and ICF adults, versions in site documents and patient-facing materials). Materials available in multiple languages (English, Spanish, Italian documents/synopses present). No assent/minor consent procedures described.

Geography

Total Number Of Sites
9
Total Number Of Participants
50

Spain

Earliest CTIS Part Ii Submission Date
08-01-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
464
Number Of Sites
5
Number Of Participants
25

Sites

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
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
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
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

Italy

Earliest CTIS Part Ii Submission Date
06-12-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
496
Number Of Sites
4
Number Of Participants
25

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
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
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

Sponsor

Primary sponsor

Full Name
Advenchen Pharmaceuticals LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Bioagilytix Labs LLC
Responsibilities
sponsorDuties code 4; bioanalytical/ laboratory services (contact mindy.christlieb@bioagilytix.com as listed)
Name
Sofpromed Investigacion Clinica S.L.
Responsibilities
sponsorDuties code 1; site/clinical operations support (contact afernandez@sofpromed.com as listed)
Name
Tempus Labs Inc.
Responsibilities
sponsorDuties code 4; data/analysis services (contact scott.stone@tempus.com as listed)

Third parties

  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties code 4; contact mindy.christlieb@bioagilytix.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Sofpromed Investigacion Clinica S.L.","duties_or_roles":"sponsorDuties code 1; contact afernandez@sofpromed.com","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Tempus Labs Inc.","duties_or_roles":"sponsorDuties code 4; contact scott.stone@tempus.com","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
AL8326
Active Substance
AL8326
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Starting Dose
40 mg
Dose Levels
40 mg; 60 mg; 80 mg (80 mg cohort stopped due to high intolerability)
Frequency
Daily (QD)
Maximum Dose
80 mg
Dose Escalation Increase
Initial doses studied: 40 mg and 60 mg (randomized); 80 mg was tested but stopped for intolerability

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