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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

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

ACR-2316 · 1 trial · 1 indication

Phase 1 1
NCT06667141Phase 1 Study of ACR-2316 in Specific Advanced Solid TumorsSpecific Advanced Solid Tumors
RECRUITING100 Analytics
PHASE1RECRUITING
Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
Specific Advanced Solid Tumors
NCT06667141100
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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 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. 4. Subjects should have received no more than 3 lines of systemic therapy for r...

Countries:United States
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Frequently asked questions about ACR-2316

What is ACR-2316 used for?

ACR-2316 is an investigational small molecule being developed for the treatment of specific advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with advanced solid tumors who meet specific eligibility criteria.

Who is developing ACR-2316?

ACR-2316 is being developed by Acrivon Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACRV. The company is conducting a Phase 1 clinical trial of ACR-2316 in the United States for the treatment of specific advanced solid tumors.

What phase is ACR-2316 in?

ACR-2316 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is currently recruiting participants in the United States and is designed to evaluate the drug in patients with specific advanced solid tumors.

What clinical trials is ACR-2316 in?

ACR-2316 is being studied in a Phase 1 clinical trial with the identifier NCT06667141. This trial is titled 'Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors' and is currently recruiting participants in the United States. The trial aims to enroll approximately 100 patients aged 18 years and older.

Is ACR-2316 a controlled trial?

Yes, the Phase 1 clinical trial of ACR-2316 (NCT06667141) is a controlled trial. However, it is not randomized and not double-blind. The trial is open to all sexes and does not require healthy volunteers, as it is studying patients with specific advanced solid tumors.