A Phase 1B/2 Study of ACR-368 Alone and with Gemcitabine in People with Ovarian, Endometrial, or Urothelial Cancer


Full Title

ACR-368-201: A Phase 1B/2 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


Researchers in this study are assessing the drug ACR-368 alone and in combination with increasing doses of low-dose gemcitabine in people with ovarian, endometrial, or urothelial (bladder) cancer that has come back despite prior treatment. ACR-368 works by stopping cancer cells from repairing damage to themselves and their DNA (genes). Gemcitabine damages the DNA inside cancer cells and prevents the cells from multiplying.

Participants in this study will receive either ACR-368 alone or ACR-368 plus low-dose gemcitabine, depending in the results of a test called OncoSignature (which measures the level of specific proteins in tumor cells). Both medications are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have ovarian, endometrial, or urothelial cancer that came back despite prior treatment.
  • At least 2 weeks must pass between the completion of previous treatments and receipt of the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information about this study and to ask about eligibility, please contact Dr. Jonathan Rosenberg at 646-422-4461 or Dr. Chrisann Kyi at 646-888-4221.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID