Study of ACR-2316 in Specific Advanced Solid Tumors
Sponsor: Acrivon Therapeutics
ClinicalTrials ID:NCT06667141
This Phase 1/2 trial evaluates ACR-2316's safety, tolerability, and anti-tumor activity in advanced solid tumors. It aims to establish the maximal tolerated dose and pharmacokinetics. Eligible participants must have progressed after prior treatment, have measurable disease, and meet specific health criteria. Exclusions include recent systemic therapy and symptomatic brain metastases.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria (all participants):
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HonorHealth Research Institute | 85016 | Phoenix | Arizona |
| Precision NextGen Oncology & Research Center | 90212 | Beverly Hills | California |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| Denver Health One | 80218 | Denver | Colorado |
| Florida Cancer Specialist | 34232 | Sarasota | Florida |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| Roswell Park Comprehensive Cancer Center | 14203 | Buffalo | New York |
| Montefiore Medical Centre | 10461 | The Bronx | New York |
| Carolina BioOncology Institute | 28078 | Huntersville | North Carolina |
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