What is the purpose of this study?
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.
Eligibility
- 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.
(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.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors
- Disease Type/ConditionSpecific Advanced Solid Tumors
- Principal InvestigatorMonica M. Mita, MD
- Co-InvestigatorsAlain Mita, MD, Carlos R. Becerra, MD, Chaitali S. Nangia, MD, Laura Beals, NP, Yaser Homsi, MD, Simon Khagi, MD, David J. Benjamin, MD, Tara E. Seery, MD, Tiffany L. Beck, MD, Adrienne Norquist, NP, Kathleen Riel, NP
- Age GroupAdult, Older Adult
- PhaseI
- ClinicalTrials.gov IDNCT06667141
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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