Study of RP-3500 in Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Mar 30, 2024
  • participants needed
    457
  • sponsor
    Repare Therapeutics
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Updated on 7 October 2022
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Summary

The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine a recommended Phase 2 dose (RP2D) and schedule of orally-administered RP-3500 alone or in combination with talazoparib, a PARP inhibitor, or Gemcitabine in patients with advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate the safety and tolerability of RP-3500 alone or in combination with talazoparib or gemcitabine, examine both the pharmacokinetics (PK)and pharmacodynamics (PD)and investigate its anti-tumor activity in solid tumors. An evaluation of safety and tolerability in children over 4 years old will be initiated.

Description

This is a first-in-human, Phase 1/2a, multi-center, open-label, dose-escalation and expansion study to:

  • Evaluate the safety profile and MTD of RP-3500 when administered orally, alone and in combination with talazoparib or gemcitabine, to establish the dose and schedule recommended for the Phase 2
  • Characterize the PK profile of RP-3500 alone or in combination with talazoparib or gemcitabine
  • Identify anti-tumor activity associated with RP-3500 given alone or in combination with talazoparib or gemcitabine
  • Examine biomarker responses and establish a correlation with RP-3500 exposure and clinical outcomes.
  • Evaluate the safety and tolerability of RP-3500 in pediatric patients with advanced solid tumors to establish the dose and schedule recommended for the Phase 2

The initial cohorts will test RP-3500 as monotherapy. Additional cohorts will enroll with RP-3500 in combination with talazoparib or gemcitabine.

After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 will be enrolled to study the anti-tumor effect, and further examine the safety and PK of RP-3500 at the RP2D

Details
Condition Advanced Solid Tumor
Treatment Talazoparib, RP-3500, Talazoparib: oral PARP inhibitor, Gemcitabine Injection [Gemzar]
Clinical Study IdentifierNCT04497116
SponsorRepare Therapeutics
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Written informed consent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
Male or female and <18 years-of-age at the time of signature of the consent/assent
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy
Measurable disease as per RECIST v1.1 or INRC
Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a certified lab per institutional guidelines
Available tumor tissue
Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments
Ability to swallow and retain oral medications
Acceptable organ function at screening
Acceptable blood counts at screening
Negative pregnancy test (serum or urine) for females of childbearing potential at Screening and prior to first study drug. Females who are not of childbearing potential are defined as 1) prior to onset of menses 2) documented infertility
Resolution of all toxicities of prior treatment or surgery
Male patients with female partners of childbearing potential and females of childbearing potential must follow a contraception method (oral contraceptives allowed) during their participation in the study and for at least 6 months following last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study and for 3 months following last dose of study drug

Exclusion Criteria

Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 14 days prior to first dose of study drug
History or current condition (such as transfusion dependent anemia or thrombocytopenia), 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
Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor
Known hypersensitivity to any of the ingredients of RP-3500
Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the patient's safety
Uncontrolled, symptomatic brain metastases
Uncontrolled high blood pressure
Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
Moderate or severe hepatic impairment (ie, Child-Pugh class B or C)
History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
History of ventricular dysrhythmias or risk factors such as structural heart disease, coronary heart disease (clinically significant electrolyte abnormalities or family history of sudden unexplained death or long QT syndrome
Current treatment with medications that are well-known to prolong the QT interval
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
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