Overview
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.
Description
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 preliminary evaluation of anti-tumor activity.
Eligibility
Inclusion Criteria:
- Signed written informed consent.
- Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
- 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 or radiation therapy within 2 weeks prior to the first dose of study drug.
- Women who are pregnant or lactating.