Ph Ib/II ACR-368 as Monother& Comb w/Gemcitabine in Plat-Res Ovarian Ca Endometrial Adenoca &Urothel
UCI Specialty Area: Cancer
Principal Investigator:
Nataliya Mar
Official Title:
A Phase Ib/II Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status
A Study On:
Corpus Uteri
Kidney
Other Urinary
Ovary
Urinary Bladder
Study Description
This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with ultralow dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.
Eligibility
- Participant must have histologically confirmed, locally advanced (i.e., not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
- Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after signed informed consent.
- Participant must have an estimated life expectancy of longer than 3 months.
- Participant with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent).
- Participants has known human immunodeficiency virus, hepatitis B, or hepatitis C infection that is considered uncontrolled
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