Study of ACR-2316 in Specific Advanced Solid Tumors
ConditionSpecific Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcrivon Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
ACR-2316
DrugACR-2316 is an experimental drug
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Dose escalationExperimental treatment 1 intervention
Group B: Dose expansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Escalation
To determine the MTD of ACR-2316.
Time frame
Number of DLT events during the DLT observation period (up to 28 days)2
Dose Expansion
To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity
Time frame
RP2D supported by safety, PK and PD data through study completion3
Dose Expansion
To assess the safety and tolerability of ACR-2316
Time frame
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.4
Dose Expansion
To determine preliminary anti-tumor activity of ACR-2316.
Time frame
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.Secondary outcomes
1
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.
Time frame
This will be evaluated through study completion2
Dose Escalation
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Time frame
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 3.3
Dose Escalation
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Time frame
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 3.4
Dose Escalation
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov