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:  NCT05302921

Description

• This is a phase II, single-arm, open-label, multi-site trial studying the combination of cryoablation therapy and dual checkpoint inhibition with nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) given at the recommended phase 2 dose (RP2D) in pediatric and young adult patients with relapsed or refractory solid tumors.

Key Eligibility Criteria

• Ages ≥ 1 year and <40 years old
• Relapsed/refractory solid tumors and at least 2 sites of measurable disease

Sponsor

• Children's National Hospital

Investigator

• AeRang Kim, M.D.

Disease Type

• Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, and other solid tumors

ClinicalTrials.gov Identifier:  NCT05093322

Description

• A Phase 1/2 study to establish a recommended Phase 2 dose (RP2D) of nivolumab in combination with 5-azacytidine in children with relapsed or refractory AML and to assess the clinical activity of Nivolumab in combination with 5-azacytidine in AML patients with M2/M3 disease at study entry.

Key Eligibility Criteria

• Part 1 and 2: ages ≥ 2 and ≤ 21 years old (< 30 in the osteosarcoma cohort)
• Part 1:  recurrent or refractory solid tumors or lymphoma, that have a known or expected dysfunction of VEGFR-1, -2, and -3; FGFR-1; or CSF-1R pathways
• Part 2: recurrent or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma (NRSTS)

Sponsor

• Hutchison MediPharma Limited

Investigator

• AeRang Kim, M.D.

Disease Type

• Lymphoma,  osteosarcoma, Ewing sarcoma, rhabdomyosarcoma,  non-rhabdomyosarcoma (NRSTS), other solid tumors

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:  NCT04145349

Description

• A Phase 1/2 study to investigate the efficacy of ramucirumab in combination with low-dose cyclophosphamide and vinorelbine for the treatment of pediatric and young adult patients with desmoplastic small round cell tumor (DSRCT).

Key Eligibility Criteria

• Ages 12 months to ≤ 29 years old
• Relapsed, recurrent, or refractory DSRCT

Sponsor

• Eli Lilly and Company

Investigator

• AeRang Kim, M.D.

Disease Type

• Desmoplastic small round cell tumor

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:  NCT05071209

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 A1: Patients with specified recurrent or refractory solid tumors or lymphomas without bone marrow involvement  ≥ 12 months and < 18 years of age
• Part B1a: Patients with any Ewing Sarcoma or any EWS-fusion-positive solid tumor ≥ 18 years of age
• Part B2a: Patients with alveolar rhabdomyosarcoma (ARMS) with the PAX3-FOXO1 fusion ≥ 18 years of age
• Part B3a: Patients with any (non-CNS primary) solid tumor including lymphoma with inactivation of any of the DNA Damage Repair (DDR) genes ≥ 18 years of age

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Ewing sarcoma, alveolar rhabdomyosarcoma with PAX-FOXO1 fusion, non-CNS primary solid tumor including lymphoma with inactivation of DDR genes

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: NCT: pending

Description

• A Phase 2 study to determine treatment safety and efficacy of MR-HIFU ablation of painful osteoid osteoma in children and young adults.

Key Eligibility Criteria

• Painful osteoid osteoma
• Ages ≤ 30 years

Sponsor

• Children's National Hospital

Investigator

• Karun Sharma, M.D.

Disease Type

• Osteoid osteoma

ClinicalTrials.gov Identifier: NCT03458728

Description

• Phase 1/2 study of copanlisib for pediatric patients with a relapsed/refractory solid tumor or lymphoma.

Key Eligibility Criteria

Phase 1

• Recurrent/refractory solid tumors or lymphoma
• Ages 6 months to ≤ 21 years old

Phase 2

• Recurrent/refractory Ewing sarcoma, rhabdomyosarcoma, osteosarcoma or neuroblastoma
• Ages 6 months old to ≤21 years old

Sponsor

• Bayer Pharmaceuticals

Investigator

• AeRang Kim, M.D.

Disease Type

• Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, neuroblastoma, lymphoma, solid tumors

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: NCT02536183

Description

• A Phase 1 trial of LTLD with MR-HIFU in children and young adults with relapsed/refractory solid tumors.

Key Eligibility Criteria

• Relapsed/refractory solid tumors
• Target lesion(s) must be located in areas accessible to HIFU
• Ages ≤ 21 years of age

Sponsor

• Children's National Hospital

Investigator

• AeRang Kim, M.D.

Disease Type

• Solid tumors

ClinicalTrials.gov Identifier: NCT03834961

Description

• A Phase 2 study of larotrectinib, a highly selective oral small molecule inhibitor of the TRK family of tyrosine kinases which are encoded by the NTRK genes in select pediatric cancers.

Key Eligibility Criteria

• Cohort A: histologic diagnosis of infantile fibrosarcoma
• Cohort B: histologic diagnosis of any solid tumor including CNS tumors but excluding high-grade gliomas, with an NTRK1, NTRK2, or NTRK3 fusion
• Cohort C: histologic diagnosis of relapsed/refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion
• Ages ≤ 30 years of age

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Infantile fibrosarcoma, TRK fusion solid tumors, including CNS and TRK Fusion acute leukemias

ClinicalTrials.gov Identifier: NCT03709680

Description

• This is a Phase 1 study of palbociclib in combination with chemotherapy (irinotecan and temozolomide or topotecan and cyclophosphamide) in pediatric patients with recurrent/refractory solid tumors.

Key Eligibility Criteria

• Recurrent/refractory solid tumors, including CNS tumors
• Age ≥ 2 to < 21 years

Sponsor

• Pfizer

Investigator

• AeRang Kim, M.D.

Disease Type

• All solid tumors, CNS

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