Study of ACR-2316 in Specific Advanced Solid Tumors
ACR-2316-101: Phase 1/2 Study of ACR-2316 in Subjects With Advanced Solid Tumors
This is a first in-human, Open-label Phase 1/2 study to assess the safety and activity of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
The Phase 1/2 monotherapy clinical trial for ACR-2316 is designed to assess the safety, tolerability and preliminary evaluation of anti-tumor activity of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Mansoor R Mirza, MD
- Numero di telefono: 617-207-8979
- Email: ACR-2316ClinicalTrial@acrivon.com
Backup dei contatti dello studio
- Nome: Tiffany Crowell
- Email: ACR-2316ClinicalTrial@acrivon.com
Luoghi di studio
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85016
- Reclutamento
- HonorHealth Research Institute
-
Investigatore principale:
- Lyndsay Willmott, MD
-
Contatto:
- Amy Petersburg
-
-
California
-
Beverly Hills, California, Stati Uniti, 90212
- Reclutamento
- Precision NextGen Oncology & Research Center
-
Contatto:
- Francisco Capilla
-
Investigatore principale:
- Kamlesh K Sankhala, MD
-
Newport Beach, California, Stati Uniti, 92663
- Reclutamento
- Hoag Memorial Hospital Presbyterian
-
Investigatore principale:
- Monica Mita, MD
-
Contatto:
- Ariel Klingfus
-
-
Colorado
-
Denver, Colorado, Stati Uniti, 80218
- Reclutamento
- Denver Health One
-
Investigatore principale:
- Gerald Falchook, MD
-
Contatto:
- Rachel Morgan
-
-
Florida
-
Sarasota, Florida, Stati Uniti, 34232
- Reclutamento
- Florida Cancer Specialist
-
Investigatore principale:
- Judy S Wang, MD
-
Contatto:
- Mallory Hawkins
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02215
- Reclutamento
- Beth Israel Deaconess Medical Center
-
Investigatore principale:
- Gerburg Wulf, MD
-
Contatto:
- Victoria Weden
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109
- Reclutamento
- University of Michigan
-
Contatto:
- Fatima Darwiche
-
Investigatore principale:
- Zhen Ni Zhou, MD
-
-
New York
-
Buffalo, New York, Stati Uniti, 14203
- Reclutamento
- Roswell Park Comprehensive Cancer Center
-
Investigatore principale:
- Anuradha Krishnamurthy, MD
-
Contatto:
- Paige Wierzbicki
-
The Bronx, New York, Stati Uniti, 10461
- Reclutamento
- Montefiore Medical Centre
-
Investigatore principale:
- Nicole Nevadunsky, MD
-
Contatto:
- Sene Martin
-
-
North Carolina
-
Huntersville, North Carolina, Stati Uniti, 28078
- Reclutamento
- Carolina BioOncology Institute
-
Investigatore principale:
- Neel Gandhi, MD
-
Contatto:
- Hannah Wall
-
-
Rhode Island
-
Providence, Rhode Island, Stati Uniti, 02903
- Reclutamento
- Rhode Island Hospital
-
Investigatore principale:
- Benedito Carneiro, MD
-
Contatto:
- Megan Faria
-
-
Tennessee
-
Franklin, Tennessee, Stati Uniti, 37067
- Reclutamento
- Tennessee Oncology
-
Investigatore principale:
- Jeff Russell, MD
-
Contatto:
- Catt Pecknold
-
-
Texas
-
Houston, Texas, Stati Uniti, 77054
- Reclutamento
- The University of Texas MD Anderson Cancer Center
-
Investigatore principale:
- Timothy A Yap, MD,PhD
-
Contatto:
- CR Registration Team Office of Clinical Research
-
San Antonio, Texas, Stati Uniti, 78229
- Reclutamento
- NEXT Oncology
-
Investigatore principale:
- David Sommerhalder, MD
-
Contatto:
- Jordan Georg
-
-
Virginia
-
Fairfax, Virginia, Stati Uniti, 22031
- Reclutamento
- Next Virginia
-
Investigatore principale:
- Mohamad Salkeni, MD
-
Contatto:
- Blake Patterson
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Signed written informed consent.
- Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
- Must be willing to provide redacted pathology report and next-generation sequencing (NGS) reports.
- Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
- Adequate organ functions.
- Must have progressed after prior line of treatment.
Exclusion Criteria (all participants):
- Participants with known symptomatic brain metastases.
- Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
- Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
- Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
- Women who are pregnant or lactating.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Dose escalation
ACR-2316 will be administered using a 3-week or a 4-week schedule. |
ACR-2316 is an experimental drug |
|
Sperimentale: Dose expansion
ACR-2316 will be administered using a 3-week schedule. |
ACR-2316 is an experimental drug |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dose Escalation
Lasso di tempo: Number of DLT events during the DLT observation period (up to 28 days)
|
To determine the MTD of ACR-2316. |
Number of DLT events during the DLT observation period (up to 28 days)
|
|
Dose Expansion
Lasso di tempo: RP2D supported by safety, PK and PD data through study completion
|
To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity |
RP2D supported by safety, PK and PD data through study completion
|
|
Dose Expansion
Lasso di tempo: Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.
|
To assess the safety and tolerability of ACR-2316 |
Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.
|
|
Dose Expansion
Lasso di tempo: Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.
|
To determine preliminary anti-tumor activity of ACR-2316. |
Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dose Escalation
Lasso di tempo: This will be evaluated through study completion
|
To assess the safety and tolerability of ACR-2316. Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. |
This will be evaluated through study completion
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: apparent volume of distribution (Vz/F). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: terminal elimination half-life (t½). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Escalation
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: apparent oral clearance (CL/F). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: apparent volume of distribution (Vz/F). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: terminal elimination half-life (t½). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
|
Dose Expansion
Lasso di tempo: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
To assess Pharmacokinetics: apparent oral clearance (CL/F). |
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
|
Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Processi patologici
- Malattie neuromuscolari
- Attributi della malattia
- Malattie genetiche, congenite
- Malattie del sistema nervoso periferico
- Malattie Neurodegenerative
- Anomalie congenite
- Malattie Eredodegenerative, Sistema Nervoso
- Malformazioni del sistema nervoso
- Polineuropatie
- Malattie e anomalie congenite, ereditarie e neonatali
- Condizioni patologiche, segni e sintomi
- Ricorrenza
- Neuropatie sensoriali e autonomiche ereditarie
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- ACR-2316-101
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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