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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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 2/28/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Felipe Batalini, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Kostandinos Sideras, M.D., Ph.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

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