About this trial
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
Eligibility criteria
Qualifiers
Male or female and ≥12 years-of-age at the time of informed consent.
Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients >16 years of age.
Locally advanced or metastatic resistant or refractory solid tumors.
Patients <18 years of age must weigh at least 40 kg.
Disqualifiers
Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, 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.
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.
Trial design
Treatments tested in this trial
- Lunresertib
- RP-3500
- Debio0123