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

Description

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.

Conditions

Advanced Cancer, Metastatic Solid Tumor

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Study Overview

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Study Details

Study overview

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.

Phase 1/2 Study of TPX-0005 (Repotrectinib) in Combination with Chemotherapy in Pediatric and Young Adult Subjects with Advanced or Metastatic Solid Tumors and Primary Central Nervous System Tumors

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

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Phase 1- patients with known bone marrow disease
  • * Concurrent participation in another therapeutic clinical trial
  • * Neuroblastoma patients with only bone marrow disease evaluable only by bone marrow aspiration
  • * 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.

Ages Eligible for Study

1 Year to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Emily Slotkin, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2028-08