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

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.

The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability 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, and preliminary evaluation of anti-tumor activity.

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 recurrent disease.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
6. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
7. Adequate organ functions.
8. Must have progressed after prior line of treatment.

Exclusion Criteria (all participants):

1. Participants with known symptomatic brain metastases.
2. Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
3. Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
4. Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
5. Women who are pregnant or lactating.