Study Details

Open

A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma

This is a Phase 1b/2, multicenter, open-label, basket study evaluating ACR-368, an adenosine triphosphate-competitive selective inhibitor of checkpoint kinase (CHK)1 and CHK2, as monotherapy and in combination with ultralow-dose gemcitabine (ULDG), in the treatment of subjects with histologically confirmed, locally advanced or metastatic, recurrent platinum-resistant high-grade ovarian or endometrial adenocarcinoma, or platinum-resistant urothelial carcinoma (hereafter referred to as ovarian, endometrial, and urothelial, respectively).

Age & Gender

18 years ~ 99 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina

What will be asked of you

You will be in the study for about 12 months, depending on disease progression. During that time the study involves physical exam, vital signs, blood draws for labs and research, variety of imaging procedures that include, CT and MRI scans, electronic questionnaires, study drug, and study drug infusions.

Incentives

Yes, the study medications, including ACR-368 and gemcitabine (if you are in Arm 2), required by the study are provided at no cost while taking part in the study.

Total length of participation:
Varies depending on arm of study

Looking for Specific Volunteers

Able to participate:

Patient must have confirmed locally advanced or metastatic cancer (cancer that has spread) that has progressed during or after at least one prior therapy.
Patient must have at least one measurable lesion via imaging scan.
Patient must be willing to provide tissue from a newly obtained biopsy, up to six weeks prior to starting study treatment.
Patient must have stabilized or resolved toxicities from any previous therapy.
Patient must have an estimated life expectancy greater than three months.

Not eligible if:

Patient has known symptomatic brain metastases (some exceptions apply).
Patient received systemic or radiation therapy within two weeks of the first dose of study drug treatment.
Patient has known HIV, hepatitis B, or hepatitis C infection that is uncontrolled.
Patient has had major surgery within four weeks of screening.
Patient has a history of another cancer within two years prior to enrollment (some exceptions apply).

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Matthew Milowsky
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Other Cancers, Uterine (endometrial), Ovarian)
Urinary and Bladder
Women's Health

IRB Number

23-1001

ClinicalTrials.gov

NCT05548296