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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Mansoor R Mirza, MD
- Telefonnummer: 617-207-8979
- E-mail: ACR-2316ClinicalTrial@acrivon.com
Undersøgelse Kontakt Backup
- Navn: Tiffany Crowell
- E-mail: ACR-2316ClinicalTrial@acrivon.com
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85016
- Rekruttering
- HonorHealth Research Institute
-
Ledende efterforsker:
- Lyndsay Willmott, MD
-
Kontakt:
- Amy Petersburg
-
-
California
-
Beverly Hills, California, Forenede Stater, 90212
- Rekruttering
- Precision NextGen Oncology & Research Center
-
Kontakt:
- Francisco Capilla
-
Ledende efterforsker:
- Kamlesh K Sankhala, MD
-
Newport Beach, California, Forenede Stater, 92663
- Rekruttering
- Hoag Memorial Hospital Presbyterian
-
Ledende efterforsker:
- Monica Mita, MD
-
Kontakt:
- Ariel Klingfus
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80218
- Rekruttering
- Denver Health One
-
Ledende efterforsker:
- Gerald Falchook, MD
-
Kontakt:
- Rachel Morgan
-
-
Florida
-
Sarasota, Florida, Forenede Stater, 34232
- Rekruttering
- Florida Cancer Specialist
-
Ledende efterforsker:
- Judy S Wang, MD
-
Kontakt:
- Mallory Hawkins
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center
-
Ledende efterforsker:
- Gerburg Wulf, MD
-
Kontakt:
- Victoria Weden
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- Rekruttering
- University of Michigan
-
Kontakt:
- Fatima Darwiche
-
Ledende efterforsker:
- Zhen Ni Zhou, MD
-
-
New York
-
Buffalo, New York, Forenede Stater, 14203
- Rekruttering
- Roswell Park Comprehensive Cancer Center
-
Ledende efterforsker:
- Anuradha Krishnamurthy, MD
-
Kontakt:
- Paige Wierzbicki
-
The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Montefiore Medical Centre
-
Ledende efterforsker:
- Nicole Nevadunsky, MD
-
Kontakt:
- Sene Martin
-
-
North Carolina
-
Huntersville, North Carolina, Forenede Stater, 28078
- Rekruttering
- Carolina BioOncology Institute
-
Ledende efterforsker:
- Neel Gandhi, MD
-
Kontakt:
- Hannah Wall
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rekruttering
- Rhode Island Hospital
-
Ledende efterforsker:
- Benedito Carneiro, MD
-
Kontakt:
- Megan Faria
-
-
Tennessee
-
Franklin, Tennessee, Forenede Stater, 37067
- Rekruttering
- Tennessee Oncology
-
Ledende efterforsker:
- Jeff Russell, MD
-
Kontakt:
- Catt Pecknold
-
-
Texas
-
Houston, Texas, Forenede Stater, 77054
- Rekruttering
- The University of Texas MD Anderson Cancer Center
-
Ledende efterforsker:
- Timothy A Yap, MD,PhD
-
Kontakt:
- CR Registration Team Office of Clinical Research
-
San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- NEXT Oncology
-
Ledende efterforsker:
- David Sommerhalder, MD
-
Kontakt:
- Jordan Georg
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Next Virginia
-
Ledende efterforsker:
- Mohamad Salkeni, MD
-
Kontakt:
- Blake Patterson
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Dose escalation
ACR-2316 will be administered using a 3-week or a 4-week schedule. |
ACR-2316 is an experimental drug |
|
Eksperimentel: Dose expansion
ACR-2316 will be administered using a 3-week schedule. |
ACR-2316 is an experimental drug |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dose Escalation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dose Escalation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
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Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- ACR-2316-101
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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