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ACR-2316

Phase 1

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

ACR-2316 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

ACR-2316 clinical trials

ACR-2316 · 1 trial · 1 indication

Phase 1 1
NCT06667141Study of ACR-2316 in Specific Advanced Solid TumorsSpecific Advanced Solid Tumors
RECRUITING100 Analytics
PHASE1RECRUITING
Study of ACR-2316 in Specific Advanced Solid Tumors
Specific Advanced Solid TumorsUnlock trial analytics

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 and PD data through study completion

To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity

Secondary Endpoints

Dose Escalation
This will be evaluated through study completion
Dose Expansion
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
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Study Design & Arms

AllocationRANDOMIZED
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 schedule.

Interventions

NameTypeDescription
ACR-2316DRUGACR-2316 is an experimental drug
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Eligibility Criteria

Age Range18 Years to 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 and next-generation sequencing (NGS) reports. 4. Subjects should have received n...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 23, 2026NCT06667141lastUpdatePostDate: changed
LOWSep 23, 2026NCT06667141lastUpdatePostDate: changed
MEDIUMSep 21, 2026NCT06667141primaryCompletionDate: changed
MEDIUMSep 21, 2026NCT06667141primaryCompletionDate: changed

Frequently asked questions about ACR-2316

What is ACR-2316?

ACR-2316 is an investigational small molecule developed by Acrivon Therapeutics, Inc. for the treatment of specific advanced solid tumors. It is in Phase 1 clinical development and is being evaluated in a single recruiting study in the United States. It is not an approved therapy.

What is ACR-2316 used for?

ACR-2316 is being studied for the treatment of specific advanced solid tumors in adults. The Phase 1 trial enrolls patients 18 years and older with these tumor types. Because it remains investigational, ACR-2316 is not approved for any use outside of clinical research.

Who is developing ACR-2316?

ACR-2316 is being developed by Acrivon Therapeutics, Inc., which trades on the Nasdaq under the ticker ACRV. The company is the sponsor of the Phase 1 study evaluating the small molecule in patients with specific advanced solid tumors.

What phase is ACR-2316 in?

ACR-2316 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting participants, and no trials of ACR-2316 have been completed. The program has not reached later-stage development, and the drug is investigational rather than approved.

What clinical trial is ACR-2316 in?

ACR-2316 is being evaluated in the Phase 1 study NCT06667141, titled Study of ACR-2316 in Specific Advanced Solid Tumors. The trial is recruiting, is controlled and randomized, is not double blinded, and plans to enroll approximately 100 participants across sites in the United States.

Is ACR-2316 approved by the FDA?

No. ACR-2316 is an investigational small molecule in Phase 1 clinical development and has not been approved by the FDA. It is available only to participants enrolled in its ongoing clinical trial, which is studying the drug in adults with specific advanced solid tumors.