Overview

Trial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer

Status:
Not yet recruiting
Trial end date:
2027-12-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to find out if a new drug, M4344, is safe and has beneficial effects when given in combination with the PARP inhibitor, Niraparib, in women with recurrent ovarian cancer that has progressed while on a PARP inhibitor.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Treatments:
Niraparib
Criteria
Inclusion Criteria:

- Patients must have been diagnosed with advanced epithelial serous ovarian cancer,
primary peritoneal cancer or fallopian tube cancer

- Patients must have PARP resistant ovarian cancer, defined as progression while being
treated with a PARP inhibitor.

- Patients must have at least one lesion that meets the definition of measurable disease
by RECIST v1.1.

- Patients must have received at least one but no more than five prior systemic
treatment regimens

- Female patients ≥ 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or

Exclusion Criteria:

- Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment.

- Patients cannot have had primary platinum refractory cancer, i.e. documented cancer
progression while receiving platinum or within one month of receipt of a platinum
based regimen.

- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at
baseline) from adverse events due to a previously administered agent.

- Has a known additional malignancy that is progressing or requires active treatment. In
addition, patients cannot have been diagnosed with another malignancy within 3 years
of starting treatment. Exceptions include fully resected basal cell carcinoma of the
skin or squamous cell carcinoma of the skin, in situ cervical cancer, fully resected
ductal carcinoma in situ, and stage IA, noninvasive grade I endometrioid endometrial
cancer, that has undergone curative therapy.

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may participate
provided they are stable (without evidence of progression by imaging for at least four
weeks prior to the first dose of trial treatment and any neurologic symptoms have
returned to baseline), have no evidence of new or enlarging brain metastases, and are
not using steroids for at least 7 days prior to trial treatment. This exception does
not include clinically active and significant carcinomatous meningitis that is
excluded regardless of clinical stability.

- Has an active infection requiring systemic therapy

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the participant's
participation for the full duration of the trial, or is not in the best interest of
the participant to participate, in the opinion of the treating investigator.