Brief Summary
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.
Brief Title
Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
Detailed Description
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 preliminary evaluation of anti-tumor activity.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-207-8979
Central Contact Email
ACR-2316ClinicalTrial@acrivon.com
Central Contact Role
Contact
Central Contact Email
ACR-2316ClinicalTrial@acrivon.com
Completion Date
Completion Date Type
Estimated
Conditions
Specific Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria:
1. Signed written informed consent.
2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
5. Adequate organ functions.
6. Must have progressed after prior line of treatment.
Exclusion Criteria (all participants):
1. Participants with known symptomatic brain metastases.
2. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
3. Women who are pregnant or lactating.
1. Signed written informed consent.
2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
5. Adequate organ functions.
6. Must have progressed after prior line of treatment.
Exclusion Criteria (all participants):
1. Participants with known symptomatic brain metastases.
2. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
3. Women who are pregnant or lactating.
Inclusion Criteria
Inclusion Criteria:
1. Signed written informed consent.
2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
5. Adequate organ functions.
6. Must have progressed after prior line of treatment.
1. Signed written informed consent.
2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
5. Adequate organ functions.
6. Must have progressed after prior line of treatment.
Gender
All
Gender Based
false
Keywords
ACR-2316
WEE1
PKMYT1
Locally advanced, recurrent or metastatic solid tumors
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06667141
Org Class
Industry
Org Full Name
Acrivon Therapeutics
Org Study Id
ACR-2316-101
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors
Primary Outcomes
Outcome Description
To determine the MTD of ACR-2316 based on the number of DLTs. Isotonic regression will be conducted to determine MTD
Outcome Measure
Dose Escalation
Outcome Time Frame
DLTs will be evaluated from first dose of ACR-2316 to day 21 for each subject in each dose level.
Outcome Description
To determine the RP2D of ACR-2316.
Outcome Measure
Dose Expansion
Outcome Time Frame
The RP2D will be evaluated by the incidence of DLT events per dose level through study completion, an average of 1 year.
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
This will be evaluated through study completion, an average of 1 year.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: terminal elimination half-life (t½).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
To assess Pharmacokinetics: apparent oral clearance (CL/F).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Escalation
Outcome Description
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, number of dose decreases, number of dose delays, Serious Adverse Events.
Outcome Time Frame
This will be evaluated through study completion, an average of 1 year.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: terminal elimination half-life (t½).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Outcome Description
To assess Pharmacokinetics: apparent oral clearance (CL/F).
Outcome Time Frame
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Outcome Measure
Dose Expansion
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Nevadunsky
Investigator Email
nnevadun@montefiore.org
Investigator Phone
718-405-8082