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Clinical Trial 21879

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT05147350

Phase: Phase I
Principal Investigator: Mehta, Rutika

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or 1-800-679-0775 Learn More

Overview

Study Title

Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors (MINOTAUR Study)

Summary

The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

Objective

Primary Objectives: To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors To define the MTD and the RP2D and schedule of RP-6306 in combination with FOLFIRI Secondary Objectives: To assess the preliminary efficacy of RP-6306 in combination with FOLFIRI in patients with molecularly selected, advanced solid tumors To assess PK parameters of RP-6306 in combination with FOLFIRI Exploratory Objectives: To evaluate the concordance between local and central NGS or FISH results for enrollment biomarkers To assess clinical outcomes and, where available, pharmacodynamic effects in tumors based on the tumor types and specific tumor-specific subsets: o CCNE1 amplified o Cyclin E1 protein levels o FBXW7 deleterious mutations o CRC, GI, and esophageal cancers To evaluate the PK/pharmacodynamic/efficacy relationship after treatment with RP-6306 in combination with FOLFIRI To evaluate clinical outcomes with outcomes observed in MYTHIC study (monotherapy RP-6306) and historical data for FOLFIRI, including effects on tumor types and the following tumor-specific subsets: o CCNE1 amplified o Cyclin E1 protein levels o FBXW7 deleterious mutations o CRC, GI, and esophageal cancers

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

CPT-11 (irinotecan); Camptosar (irinotecan); Fluorouracil (); RP-6306 (); irinotecan (); leucovorin ()

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.

All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease.

Measurable disease as per RECIST v1.1

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.

Exclusion Criteria

Inability to swallow and retain oral medications.

Chemotherapy or small molecule antineoplastic agent given within 21 days or > 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.

Patients who are pregnant or breastfeeding

Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.

Major surgery within 4 weeks prior to first study treatment dose.

Uncontrolled, symptomatic brain metastases.

Uncontrolled high blood pressure

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

Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) >Class 2

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

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