RecruitingAdvanced Solid Tumor

Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

Eligible age

12+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Debiopharm International SA

You may qualify if…

✓ 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.
✓ Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
✓ Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.
✓ CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
✓ FBXW7 deleterious mutations identified by either a tumor or plasma NGS test

You may not qualify if…

✕ 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.
✕ Major surgery within 4 weeks prior to first dose of lunresertib.
✕ Uncontrolled, symptomatic brain metastases.
✕ Uncontrolled hypertension.
✕ Certain prior anti-cancer therapy