Testing ACR-2316 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial evaluates the safety and tolerability of ACR-2316 in patients with specific advanced solid tumors. The study aims to determine the maximum tolerated dose and the recommended dose for future studies, while also assessing the pharmacokinetic profile of the drug and its preliminary anti-tumor activity. Participants will receive ACR-2316 and will be closely monitored for any adverse effects and treatment responses.

Why it matters

Who can join: the full rules

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 and next-generation sequencing (NGS) reports.
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.

Where it's running

• HonorHealth Research Institute
  Phoenix, Arizona, United States Recruiting
• Precision NextGen Oncology & Research Center
  Beverly Hills, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• Denver Health One
  Denver, Colorado, United States Recruiting
• Florida Cancer Specialist
  Sarasota, Florida, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Mansoor R Mirza, MD
• Email: ACR-2316ClinicalTrial@acrivon.com
• Phone: 617-207-8979

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study is testing a new cancer drug called ACR-368, alone or with a low dose of another medication, to see if it helps people with certain hard-to-treat cancers like ovarian, endometrial, and bladder cancer.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.