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This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability 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, and preliminary evaluation of anti-tumor activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | ACR-2316 will be administered using a 3-week or a 4-week schedule. |
|
| Dose expansion | Experimental | ACR-2316 will be administered using a 3-week or a 4-week schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACR-2316 | Drug | ACR-2316 is an experimental drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation | To determine the MTD of ACR-2316. | Number of DLT events during the DLT observation period (up to 28 days) |
| Dose Expansion | To determine the RP2D of ACR-2316. | RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year. |
| Dose Expansion | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation | 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, an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria (all participants):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mansoor R Mirza, MD | Contact | 617-207-8979 | ACR-2316ClinicalTrial@acrivon.com | |
| Jeanie Tang | Contact | ACR-2316ClinicalTrial@acrivon.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Recruiting | Phoenix | Arizona | 85016 | United States |
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Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum tolerated dose (MTD) determination for ACR-2316 administered per cohort
Dose expansion - participants with certain tumor types will be randomized 1:1 to receive1 of the 2 dose levels that will be selected for the determination of RP2D.
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| Dose Escalation |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 Expansion | 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 Expansion | 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 Expansion | 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 Expansion | 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 Expansion | 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 Expansion | 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 Expansion | 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 Expansion | 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. |
| Precision NextGen Oncology & Research Center | Recruiting | Beverly Hills | California | 90212 | United States |
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| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
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| Denver Health One | Recruiting | Denver | Colorado | 80218 | United States |
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| Florida Cancer Specialist | Recruiting | Sarasota | Florida | 34232 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14203 | United States |
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| Montefiore Medical Centre | Recruiting | The Bronx | New York | 10461 | United States |
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| Carolina BioOncology Institute | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| Tennessee Oncology | Recruiting | Franklin | Tennessee | 37067 | United States |
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| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77054 | United States |
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| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
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| Next Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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