A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Cancer, Metastatic Solid Tumor

In brief

This study will test the safety of the study drug, repotrectinib, in combination with chemotherapy (irinotecan and temozolomide) in children and young adults who have advanced or metastatic solid tumors. We researchers will try to find the highest dose of the study drug that causes few or mild side effects in study participants. When the researchers find this dose, we will evaluate it in a different group of participants to find out whether repotrectinib in combination with chemotherapy is an effective treatment for children and young adults who have advanced/metastatic solid tumors. Another purpose of the study is to look at the way the body absorbs, distributes, and gets rid of repotrectinib.

Key facts

Study ID

NCT05004116

Run by

Memorial Sloan Kettering Cancer Center

People needed

77

Starts

2021-08-09

Expected to finish

2028-08-01

Last updated by the study team

2026-06-04

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Phase 1- patients with known bone marrow disease
• Concurrent participation in another therapeutic clinical trial
• Major surgery within 14 days (2 weeks) prior to C1D1. Central venous access (Broviac, MediPort) placement does not meet criteria for major surgery.
• Pregnancy or lactation
• Known active systemic infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity). Skin or other superficial infections requiring topical treatment only are not an exclusion.
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
• Peripheral neuropathy CTCAE grade ≥ 3.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study, or could compromise protocol objectives in the opinion of the Investigator and/or Turning Point Therapeutics.
• Current use or anticipated need for drugs that are known to be strong CYP3A4 inhibitors or inducers
• Disease progression while on treatment with irinotecan/temozolomide.
• Gilbert Syndrome or Crigler-Najjar
• Prolonged QTc: 450m/s for male patients and 470ms for female patients.

Where it is running

• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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