Actively Recruiting
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-04
77
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy before enrollment.
- Patients must not have received myelosuppressive chemotherapy within 21 days before starting protocol therapy.
- Patients must not have received biologic anti-cancer agents within 7 days before starting protocol therapy.
- Monoclonal antibody treatments must have ended at least 7 days or 3 half-lives before starting protocol therapy.
- Other immunotherapy (e.g., tumor vaccine) must have been completed at least 42 days before starting protocol therapy.
- Radiation therapy must have ended at least 2 weeks before starting treatment; if extensive bone marrow radiation, at least 42 days must have passed.
- Palliative radiotherapy during the study is allowed under certain conditions, with repotrectinib treatment interrupted around radiation.
- Patients are eligible 12 weeks after autologous hematopoietic stem cell transplant following myeloablative therapy.
- Patients who had non-myeloablative stem cell infusion are eligible anytime if other criteria are met.
- At least 6 weeks must have passed since ^131 I-MIBG therapy before starting treatment.
- Growth factor treatments must have ended 14 days (long-acting) or 7 days (short-acting) before starting treatment.
- Investigational drugs other than chemotherapy must not have been taken within 2 weeks or 5 half-lives before treatment.
- Prior tyrosine kinase inhibitor therapy does not exclude patients if stopped at least 7 days or 5 half-lives before treatment.
- Patients must have relapsed or refractory disease despite standard therapy.
- Phase 1 patients must have evaluable or measurable disease; phase 2 patients must have measurable disease.
- DIPG patients must have recurrent or progressive disease after radiation therapy.
- Archived tissue must be available for analysis (except DIPG patients) or waiver granted.
- Patients with primary CNS tumors must be neurologically stable on stable or decreasing steroids for at least 14 days before enrollment.
- Lansky or Karnofsky performance score of at least 50.
- Adequate blood counts and hemoglobin levels as specified.
- Adequate renal, liver, and cardiac function as defined.
- Females of childbearing potential must have a negative pregnancy test and agree to use two effective contraceptive methods; males must use contraception or abstain.
- Ability to comply with outpatient visits and procedures.
- Signed informed consent/assent by patient, parent, or guardian.
- Age limits: phase 1 part A and phase 2 up to 30 years old; phase 1 part B under 12 years old.
- Patients with relapsed/refractory solid tumors including those with ALK/ROS/NTRK aberrations are eligible as specified.
- Tissue analysis requirements vary by phase and cohort, including genetic testing for ALK/ROS/NTRK status.
You will not qualify if you...
- Patients with known bone marrow disease (phase 1).
- Concurrent participation in another therapeutic clinical trial.
- Major surgery within 14 days before starting treatment (placement of central venous access is allowed).
- Pregnancy or breastfeeding.
- Active systemic infections requiring treatment (except skin or superficial infections).
- Gastrointestinal diseases or malabsorption syndromes affecting drug absorption.
- Peripheral neuropathy of grade 3 or higher.
- Severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study participation or data interpretation.
- Use or anticipated need for strong CYP3A4 inhibitors or inducers.
- Disease progression while receiving irinotecan and temozolomide.
- Gilbert Syndrome or Crigler-Najjar syndrome.
- Prolonged QTc interval above specified limits for males and females.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
Research Team
E
Emily Slotkin, MD
CONTACT
F
Fiorella Iglesias Cardenas, MD,MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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