Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors
1 other identifier
interventional
100
1 country
15
Brief Summary
This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2024
CompletedFirst Submitted
Initial submission to the registry
October 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 12, 2026
March 23, 2026
March 1, 2026
1.8 years
October 23, 2024
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Dose Escalation
To determine the MTD of ACR-2316.
Number of DLT events during the DLT observation period (up to 28 days)
Dose Expansion
To determine the RP2D of ACR-2316.
RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.
Dose Expansion
To assess the safety and tolerability of ACR-2316
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.
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
This will be evaluated through study completion, an average of 1 year.
Dose Escalation
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
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
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
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.
- +14 more secondary outcomes
Study Arms (2)
Dose escalation
EXPERIMENTALACR-2316 will be administered using a 3-week or a 4-week schedule.
Dose expansion
EXPERIMENTALACR-2316 will be administered using a 3-week or a 4-week schedule.
Interventions
Eligibility Criteria
You may qualify if:
- Signed written informed consent.
- Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
- Must be willing to provide redacted pathology report.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
HonorHealth Research Institute
Phoenix, Arizona, 85016, United States
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Denver Health One
Denver, Colorado, 80218, United States
Florida Cancer Specialist
Sarasota, Florida, 34232, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
Montefiore Medical Centre
The Bronx, New York, 10461, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Tennessee Oncology
Franklin, Tennessee, 37067, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77054, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
Next Virginia
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2024
First Posted
October 31, 2024
Study Start
October 8, 2024
Primary Completion (Estimated)
August 12, 2026
Study Completion (Estimated)
December 12, 2026
Last Updated
March 23, 2026
Record last verified: 2026-03