Solid Tumor Clinical Trials

ClinicalTrials.gov Identifier:  NCT04870944

Description

• This phase I/II trial evaluates the best dose, side effects, and possible benefit of CBL0137 in treating patients with relapsed, or refractory solid tumors, including central nervous system (CNS) tumors or lymphoma.

Key Eligibility Criteria

• Parts A and B1: ≥ 12 months and ≤ 21 years old
• Part B2 (relapsed/refractory osteosarcoma): ≥ 12 months and ≤ 30 years old

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Solid tumors, lymphoma

ClinicalTrials.gov Identifier:  NCT03425279

Description

• A Phase 1/2 study to define the safety profile, including dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and other safety parameters for BA3011 in patients with advanced solid tumors. Additionally, the study aims to assess antitumor activity, safety, and further characterize the clinical activity of BA3011 alone and in combination with nivolumab.

Key Eligibility Criteria

• Phase 1: Age ≥ 18 years
  Locally advanced unresectable or metastatic solid tumor
• Phase 2: Age ≥ 12 years
  Locally advanced unresectable or metastatic sarcoma 

Sponsor

• BioAlta, Inc.

Investigator

• AeRang Kim, M.D.

Disease Type

• Sarcomas, other solid tumors

ClinicalTrials.gov Identifier:  NCT04616560

Description

• A Phase 2 study to estimate the proportion of patients with recurrent measurable osteosarcoma treated with DS-8201a who are event-free (%EF) at 24 weeks, and assess the safety of DS-8201a in patients with recurrent osteosarcoma.

Key Eligibility Criteria

• Ages > 12 years and ≤ 39 years old
• Osteosarcoma and confirmed HER2 expression of >10% of osteosarcoma cells

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Osteosarcoma

ClinicalTrials.gov Identifier:  NCT04851119

Description

• A Phase 1/2 study to Investigate the safety, dosing, and efficacy of Tegavivint in children and young adults with relapsed or refractory solid tumors including desmoid tumors and lymphoma.

Key Eligibility Criteria

• Part A: ≥ 12 months and ≤ 21 years old 
• Relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors
• Part B: ≥ 12 months and ≤ 30 years
• Recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations.

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Solid tumors, including non-Hodgkin lymphoma and desmoid tumors

ClinicalTrials.gov Identifier: NCT05135975

Description

A phase 2 study to evaluate the effect of oral daily cabozantinib, administered for up to 12 months, on the one-year progression-free survival of patients with “ultra-high-risk” pediatric solid tumors.

Key Eligibility Criteria

• Diagnosis of neuroblastoma, relapsed/refractory sarcomas and other solid tumors, metastatic sarcomas after frontline therapy 
• Patients previously with measurable disease AND/OR evaluable disease
• Age:  ≥ 18 months of age and <40 years

Sponsor

Nationwide Children's Hospital

Investigator

AeRang Kim, M.D., Ph.D.

Disease Type

Solid Tumors

ClinicalTrials.gov Identifier:  NCT03611868

Description

• The study is currently a Phase 2 study assessing the overall response rate of APG-115 in combination with pembrolizumab in the treatment of patients with advanced solid tumors. Children's is enrolling for Cohort F for patients with metastatic, refractory, or unresectable malignant peripheral nerve sheath tumors.

Key Eligibility Criteria

• Malignant peripheral nerve sheath tumor
• Ages ≥ 12 years

Sponsor

• Ascentage Pharma Group Inc.

Investigator

• AeRang Kim, M.D.

Disease Type

• Malignant peripheral nerve sheath tumor

ClinicalTrials.gov Identifier: NCT03837899

Description

• This is the first time in a pediatrics study primarily designed to evaluate the safety and tolerability of durvalumab and durvalumab in combination with tremelimumab at increasing doses in pediatric patients with advanced solid malignancies including lymphomas.

Key Eligibility Criteria

• Relapsed/refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, other sarcomas, neuroblastoma, other solid tumors, Hodgkin's lymphoma, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, juvenile myelomonocytic leukemia
• Ages birth to <18 years old

Sponsor

• AstraZeneca

Investigator

• Marie Nelson, M.D.

Disease Type

• Osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, other sarcomas, neuroblastoma, other solid tumors, Hodgkin's lymphoma, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, juvenile myelomonocytic leukemia

ClinicalTrials.gov Identifier: NCT04791228

Description

• A pilot trial of LTLD combined with MR-HIFU hyperthermia followed by ablation therapy in subjects with relapsed/refractory solid tumors.

Key Eligibility Criteria

• Relapsed/refractory solid tumors
• Ages ≥ 12 years of age 
• Target lesion(s) must be accessible to MR-HIFU

Sponsor

• Children's National Hospital

Investigator

• AeRang Kim, M.D.

Disease Type

• Solid tumors

ClinicalTrials.gov Identifier: NCT03690869

Description

• A study evaluating  REGN2810, a human monoclonal antibody targeting the PD-1 receptor in pediatric patients with relapsed or refractory solid or central nervous system tumors.

Key Eligibility Criteria

• Newly diagnosed diffuse intrinsic pontine glioma, high-grade glioma, recurrent high-grade glioma, and solid tumors
• Primary diagnosis of high-grade glioma of the spinal cord or disseminated disease not eligible
• Ages 3 to 25 years

Sponsor

• Pacific Neuro-Oncology Consortium

Investigator

• Lindsay Kilburn, M.D.

Disease Type

• Diffuse intrinsic pontine glioma, high-grade glioma, recurrent high-grade glioma, solid tumors

ClinicalTrials.gov Identifier: NCT02601937

Description

• This is a phase 1 study of tazemetostat for patients with INI1-negative tumors of CNS or rhabdoid solid tumors.

Key Eligibility Criteria

• Relapsed/refractory disease of malignant rhabdoid tumors, including CNS
• Ages > 6 months to < 18 years

Sponsor

• Epizyme

Investigator

• Lindsay Kilburn, M.D.

Disease Type

• Rhabdoid tumors, INI1 negative tumors include CNS tumors

ClinicalTrials.gov Identifier: NCT03206021

Description

• Phase 1/1b study of the combination of azacitidine and carboplatin for CNS ependymomas and childhood solid tumors.

Key Eligibility Criteria

• Recurrent/refractory brain or solid tumor including recurrent/refractory ependymomas
• Tissue from diagnosis or resection is required
• Ages 1 to < 18 years

Sponsor

• The Hospital for Sick Children 

Investigator

• Eugene Hwang, M.D.

Disease Type

• CNS ependymoma, solid tumors

ClinicalTrials.gov Identifier: NCT04465643

Description

• An open label study to evaluate the safety and feasibility of neoadjuvant Nivolumab plus Ipilimumab prior to conventional therapy (surgery, chemotherapy, radiation therapy or a combination of these) in patients with Neurofibromatosis Type 1 (NF1) and newly diagnosed pre-malignant and malignant peripheral nerve sheath tumors (MPNST) for whom surgery for resection of tumor is indicated.

Key Eligibility Criteria

• Patients must have histologically confirmed diagnosis of atypical neurofibromatous neoplasms of uncertain biologic potential (ANNUBP), low grade MPNST or high grade MPNST
• ≥ 12 years of age

Sponsor

• Johns Hopkins University School of Medicine 

Investigator

• AeRang Kim, M.D.

Disease Type

• ANNUBP, low grade MPNST or high grade MPNST

ClinicalTrials.gov Identifier: NCT05734066

Description

•  A Phase 1/2, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and efficacy of lurbinectedin monotherapy in pediatric participants with previously treated solid tumors followed by expansion to assess efficacy and safety in pediatric and young adult participants with relapsed/refractory Ewing sarcoma

Key Eligibility Criteria

• Phase 1 Part 1: Recurrent/refractory solid tumors
• Phase 1  Part 2 and Phase 2: recurrent/refractory Ewing sarcoma 
• Phase 1  Part 1: participants must be ≥ 2 to < 18 years of age.
• Phase 1  Part 2: participants must be ≥ 2 to ≤ 30 years of age.
• Phase 2: participants must be ≥ 2 to ≤ 30 years of age.

Sponsor

• Jazz Pharmaceuticals 

Investigator

• AeRang Kim, M.D.

Disease Type

• Solid Tumors

ClinicalTrials.gov Identifier: NCT05286801

Description

• A Phase 1/2 study to evaluate the safety of tiragolumab as monotherapy in pediatric patients (<18 years) with SMARCB1 or SMARCA4 deficient tumors (Part A), to evaluate antitumor activity of the combination of tiragolumab and atezolizumab in patients with SMARCB1 or SMARCA4 deficient tumors (Part B), and to evaluate the safety and adverse event profile of this combination therapy in subjects with SMARCB1 or SMARCA4 deficient tumors, with a particular focus in pediatric patients < 12 years of age.

Key Eligibility Criteria

• Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors
• Part A age: ≥ 12 years  and < 18 years 
• Part B age: ≥ 18 years

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Renal medullary carcinoma, malignant rhabdoid tumor (extra-CNS), atypical teratoid rhabdoid tumor (CNS), poorly differentiated chordoma, epithelioid sarcoma, other SMARCB1 or SMARCA4 deficient tumors

ClinicalTrials.gov Identifier: NCT05359237

Description

• A correlative study of vincristine pharmacokinetics to evaluate a new infant dosing method and determine whether it results in uniform drug exposure (AUC) across the age groups.

Key Eligibility Criteria

• Age: ≤ 12 years  
• Newly diagnosed and relapsed cancer diagnosis that is being treated with vincristine at the 1.5 mg/m2 dose level

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Any

ClinicalTrials.gov Identifier: NCT04337177

Description

• An open-label Phase I clinical trial designed to establish the recommended Phase II dose and to characterize the pharmacokinetic profile of VAL-413 when combined with temozolomide

Key Eligibility Criteria

• Recurrent Pediatric Solid Tumors
• ≥ 1 year of age or ≤ 30 years of age

Sponsor

• Valent Technologies LLC

Investigator

• AeRang Kim, M.D.

Disease Type

• Solid tumors, including CNS tumors

ClinicalTrials.gov Identifier: NCT04901702

Description

• A phase I/II study which will evaluate two treatment
  regimens; nanoliposomal irinotecan (nal-IRN, onivyde) plus talazoparib (TAL) and onivyde (ONI) plus
  temozolomide (TMZ)
• A dose finding phase I study will be open to patients with recurrent or refractory solid tumors.
• In the phase II study, patients with RR Ewing sarcoma
  will be randomized to receive either ONI plus TAL or ONI plus TMZ.

Key Eligibility Criteria

• Phase 1: refractory or recurrent non-central nervous system tumors 
• Phase 2: Refractory or recurrent Ewing sarcoma 
• Age: > 12 months and < 30 years

Sponsor

• St. Jude Children's Research Hospital

Investigator

• AeRang Kim, M.D.

Disease Type

• Solid tumors