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ACR-2316

Phase 1

Specific Advanced Solid Tumors | Small molecule | Oncology |Acrivon Therapeutics, Inc.|Last Updated: Mar 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06667141Phase 1 Study of ACR-2316 in Specific Advanced Solid TumorsPHASE1 RECRUITING 100 — — Oct 8, 2024Dec 12, 2026Mar 23, 202615 United States
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Study Endpoints
Primary Endpoints
Dose Escalation
Number of DLT events during the DLT observation period (up to 28 days)

To determine the MTD of ACR-2316.

Dose Expansion
RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.

To determine the RP2D of ACR-2316.

Secondary Endpoints
Dose Escalation
This will be evaluated through study completion, an average of 1 year.
Dose Expansion
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.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose escalationEXPERIMENTALACR-2316 will be administered using a 3-week or a 4-week schedule.
Dose expansionEXPERIMENTALACR-2316 will be administered using a 3-week or a 4-week schedule.
Interventions
NameTypeDescription
ACR-2316DRUGACR-2316 is an experimental drug
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Signed written informed consent. 2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors. 3. Must be willing to provide redacted pathology report. 4. Subjects should have received no more than 3 lines of systemic therapy for r...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06667141primaryCompletionDate: changed
LOWMay 24, 2026NCT06667141studyFirstPostDate: changed
LOWApr 8, 2026NCT06667141lastUpdatePostDate: changed
LOWApr 8, 2026NCT06667141lastUpdatePostDate: changed