Specific Advanced Solid TumorsPhase 1/2NCT06667141
Study of ACR-2316 in Specific Advanced Solid Tumors
A Phase 1/2 study testing ACR-2316 in people with Specific Advanced Solid Tumors, run by Acrivon Therapeutics at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specific Advanced Solid Tumors
- What is being tested?
- ACR-2316
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- 8 Oct 2024to 12 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
- Adequate organ functions.
- Must have progressed after prior line of treatment.
Who cannot join
- 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.
- Women who are pregnant or lactating.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tiffany Crowell contact
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Fatima Darwiche
Zhen Ni Zhou, MD
- Recruiting
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212
Francisco Capilla
Kamlesh K Sankhala, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Victoria Weden
Gerburg Wulf, MD
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Paige Wierzbicki
Anuradha Krishnamurthy, MD
- Recruiting
Denver Health One
Denver, Colorado, 80218
Rachel Morgan
Gerald Falchook, MD
- Recruiting
Next Virginia
Fairfax, Virginia, 22031
Blake Patterson
Mohamad Salkeni, MD
- Recruiting
Tennessee Oncology
Franklin, Tennessee, 37067
Catt Pecknold
Jeff Russell, MD
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77054
CR Registration Team Office of Clinical Research
Timothy A Yap, MD,PhD
- Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Hannah Wall
Neel Gandhi, MD
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Ariel Klingfus
Monica Mita, MD
- Recruiting
HonorHealth Research Institute
Phoenix, Arizona, 85016
Amy Petersburg
Lyndsay Willmott, MD
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Megan Faria
Benedito Carneiro, MD
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Jordan Georg
David Sommerhalder, MD
- Recruiting
Florida Cancer Specialist
Sarasota, Florida, 34232
Mallory Hawkins
Judy S Wang, MD
- Recruiting
Montefiore Medical Centre
The Bronx, New York, 10461
Sene Martin
Nicole Nevadunsky, MD
About this study
Official title: ACR-2316-101: Phase 1/2 Study of ACR-2316 in Subjects With Advanced Solid Tumors
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.
Read the detailed description
The Phase 1/2 monotherapy clinical trial for ACR-2316 is designed to assess the safety, tolerability and preliminary evaluation of anti-tumor activity 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 pharmacogenomics.
- Conditions
- Specific Advanced Solid Tumors
- Being tested
- ACR-2316
- Keywords
- ACR-2316, WEE1, PKMYT1, Locally advanced, recurrent or metastatic solid tumors
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACR-2316Drug
ACR-2316 is an experimental drug
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | ACR-2316 will be administered using a 3-week or a 4-week schedule. Receives: Drug: ACR-2316 |
| Dose expansion | Experimental | ACR-2316 will be administered using a 3-week schedule. Receives: Drug: ACR-2316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation
To determine the MTD of ACR-2316.
Measured: Number of DLT events during the DLT observation period (up to 28 days)
Dose Expansion
To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity
Measured: RP2D supported by safety, PK and PD data through study completion
Dose Expansion
To assess the safety and tolerability of ACR-2316
Measured: 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.
Dose Expansion
To determine preliminary anti-tumor activity of ACR-2316.
Measured: 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 (19)
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.
Measured: This will be evaluated through study completion
Dose Escalation
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: terminal elimination half-life (t½).
Measured: 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.
Dose Escalation
To assess Pharmacokinetics: apparent oral clearance (CL/F).
Measured: 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.
Dose Expansion
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: terminal elimination half-life (t½).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: apparent oral clearance (CL/F).
Measured: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start8 Oct 2024
- Primary completion12 Aug 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum tolerated dose (MTD) determination for ACR-2316 administered per cohort Dose expansion - participants with certain tumor types will be randomized 1:1 to receive 1 of the 2 dose levels that will be selected for the determination of RP2D.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acrivon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667141
- Sponsor's protocol ID
- ACR-2316-101
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACR-2316-101: Phase 1/2 Study of ACR-2316 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06667141
- Acronym / sponsor ID
- ACR-2316-101
- Conditions
- Specific Advanced Solid Tumors
- Keywords
- ACR-2316, WEE1, PKMYT1, Locally advanced, recurrent or metastatic solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acrivon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 12 Aug 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Phase 1/2 monotherapy clinical trial for ACR-2316 is designed to assess the safety, tolerability and preliminary evaluation of anti-tumor activity 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 pharmacogenomics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum tolerated dose (MTD) determination for ACR-2316 administered per cohort Dose expansion - participants with certain tumor types will be randomized 1:1 to receive 1 of the 2 dose levels that will be selected for the determination of RP2D.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: ACR-2316ACR-2316 will be administered using a 3-week or a 4-week schedule. |
| Dose expansion | Experimental | Drug: ACR-2316ACR-2316 will be administered using a 3-week schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
Key exclusion criteria (5 listed)
- 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.
- Women who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACR-2316ACR-2316 is an experimental drug | Drug | Dose escalation, Dose expansion |
Primary outcome
Dose Escalation
Time frame: Number of DLT events during the DLT observation period (up to 28 days)
To determine the MTD of ACR-2316.
Dose Expansion
Time frame: 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
Dose Expansion
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.
To assess the safety and tolerability of ACR-2316
Dose Expansion
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.
To determine preliminary anti-tumor activity of ACR-2316.
19 secondary outcomes
Dose Escalation
Time frame: This will be evaluated through study completion
Dose Escalation
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.
Dose Escalation
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.
Dose Escalation
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.
Dose Escalation
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.
Dose Escalation
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.
Dose Escalation
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.
Dose Escalation
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.
Dose Escalation
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.
Dose Escalation
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.
Dose Expansion
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.
Dose Expansion
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.
Dose Expansion
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.
Dose Expansion
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.
Dose Expansion
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.
Dose Expansion
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.
Dose Expansion
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.
Dose Expansion
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.
Dose Expansion
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiffany Crowell contact
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACR-2316 in people with Specific Advanced Solid Tumors, run by Acrivon Therapeutics at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mansoor R Mirza, MD (617-207-8979, ACR-2316ClinicalTrial@acrivon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation (time frame: Number of DLT events during the DLT observation period (up to 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.