Study of RP-3500 With Niraparib or Olaparib in Advanced Solid Tumors

Overview

About this study

The primary purpose of this study is to assess the safety and tolerability of Niraparib or Olaparib in combination with RP-3500, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 in combination with Niraparib or Olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Male or female and ≥18 years-of-age at the time of signature of the informed consent

- Confirmed advanced solid tumors resistant or refractory to standard treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

- Evaluable disease as per RECIST v1.1

- Next generation sequencing (NGS) report obtained in CLIA-certified or equivalent
laboratory demonstrating eligible tumor biomarkers.

- Submission of available tumor tissue or willingness to have a biopsy performed if safe
and feasible

- Acceptable hematologic and organ function at screening

- Negative pregnancy test for women of childbearing potential at Screening and prior to
first study drug.

- Ability to swallow and retain oral medications.

Exclusion Criteria:

- Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.

- Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 10
days or 5 half-lives (whichever is longer), prior to first dose of study drug.

- Use of radiotherapy (except for palliative reasons) within 7 days prior to first dose
of study drug.

- History or current condition, therapy, or laboratory abnormality that might confound
the study results, or interfere with the patient's participation for the full duration
of the study treatment.

- No other anticancer therapy is to be permitted while the patient is receiving study
treatment.

- Major surgery ≤28 days or minor surgical procedures ≤7 days prior to first study
treatment dose.

- Uncontrolled, symptomatic brain metastases.

- Uncontrolled high blood pressure

- History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis

- Presence of other known active invasive cancers.

- Pregnant or breastfeeding women.

- Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the study protocol and/or follow-up procedures outlined in the
protocol.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/28/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Siddhartha Yadav, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Saranya Chumsri, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Felipe Batalini, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions