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Solid Tumor Clinical Trials

For questions about new and recurrent solid tumor clinical trials, please email the research nurse coordinator, Shari Thompson, or call 202-476-2802.

TitleDescriptionKey Eligibility CriteriaSponsor  Investigator Disease Type 
ONITT, A Randomized Phase I/II Study of Onivyde in Combination with Talazoparib or Temozolomide in Children and Young Adults with Recurrent Solid Malignancies and Ewing Sarcoma
NCT04901702

 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.

  • Phase 1: refractory or recurrent non-central nervous system tumors
  • Phase 2: Refractory or recurrent Ewing sarcoma
  • Age: > 12 months and < 30 years
St. Jude Children's Research Hospital AeRang Kim, M.D.Solid tumors
PEPN22P1: A Pharmacokinetic Study of Vincristine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods
NCT05359237
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.
  • Age: ≤ 12 years
  • Newly diagnosed and relapsed cancer diagnosis that is being treated with vincristine at the 1.5 mg/m2 dose level
Children's Oncology Group AeRang Kim, M.D. Any
PEPN2121: A Phase 1/2 Study of Tiragolumab and Atezolizumab in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors
NCT05286801
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.
  • Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors
  • Part A age: ≥ 12 years and < 18 years
  • Part B age: ≥ 18 years
Children's Oncology Group AeRang Kim, M.D.Renal medullary carcinoma, malignant rhabdoid tumor (extra-CNS), atypical teratoid rhabdoid tumor (CNS), poorly differentiated chordoma, epithelioid sarcoma, other SMARCB1 or SMARCA4 deficient tumors
A Pilot Study of Lyso-thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®) and Magnetic Resonance-Guided High Intensity Focused Ultrasound (MR-HIFU) for Treatment of Relapsed or Refractory Solid Tumors
NCT04791228
This is a pilot trial of LTLD combined with MR-HIFU hyperthermia followed by ablation therapy in subjects with relapsed/refractory solid tumors.
  • Relapsed/refractory solid tumors
  • Target lesion(s) must be located at sites accessible to MR-HIFU.
  • Age: ≥ 12 years
Children's National HospitalAeRang Kim, M.D. Solid tumors

PEPN2111: A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma
NCT04870944

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.
  • Parts A and B1: ≥ 12 months and ≤ 21 years old
  • Part B2 (relapsed/refractory osteosarcoma): ≥ 12 months and ≤ 30 years old
Children's Oncology GroupAeRang Kim, M.D.Solid tumors, lymphoma

CNH-0012021: Phase II Study Investigating the Efficacy of Neoadjuvant Dual Checkpoint Inhibition and Cryoablation Therapy in Children, Adolescents, and Young Adults with Relapsed/Refractory Solid Tumors
NCT05302921

The 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.
  • Ages ≥ 1 year and <40 years old
  • Relapsed/refractory solid tumors and at least 2 sites of measurable disease
Children's National HospitalMarie Nelson, M.D.Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, and other solid tumors
BA3011-001:  A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 Alone and in Combination with Nivolumab in Adult and Adolescent Patients 12 Years and Older with Advanced Solid Tumors
NCT03425279
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.
  • Phase 1: Age ≥ 18 years
    Locally advanced unresectable or metastatic solid tumor
  • Phase 2: Age ≥ 12 years
    Locally advanced unresectable or metastatic sarcoma 
BioAlta, Inc.AeRang Kim, M.D.Sarcomas, other solid tumors
ADVL2021- J1S-MC- JV01: A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor
NCT04145349
 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).
  • Ages 12 months to ≤ 29 years old
  • Relapsed, recurrent, or refractory DSRCT
Eli Lilly and Company AeRang Kim, M.D.Desmoplastic small round cell tumor
PEPN1924: A Phase 2 Study of DS-8201a (Nsc# 807708, Ind# 153036) in Adolescents, or Young Adults with Recurrent Her2+ Osteosarcoma
NCT04616560
 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.
  • Ages > 12 years and ≤ 39 years old
  • Osteosarcoma and confirmed HER2 expression of >10% of osteosarcoma cells
Children's Oncology GroupAeRang Kim, M.D.Osteosarcoma
PEPN2011: A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
NCT04851119
 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.
  • 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.
Children's Oncology GroupAeRang Kim, M.D.Solid tumors, including non-Hodgkin lymphoma and desmoid tumors

PEPN2112: A Phase 1/ 2 Study of BAY 1895344 (elimusertib, IND#152153, NSC#810486) in Pediatric Patients with Relapsed
or Refractory Solid Tumors
NCT05071209

A Phase 1/2 study to investigate the safety, dosing and efficacy of BAY 1895344 (elimusertib) in children and young adults with relapsed or refractory solid tumors. 
  • 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
Children's Oncology GroupAeRang Kim, M.D.Ewing sarcoma, alveolar rhabdomyosarcoma with PAX-FOXO1 fusion, non-CNS primary solid tumor including lymphoma with inactivation of DDR genes
A Phase Ib/II Study of APG-115 in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors 
NCT03611868
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 advanced solid tumors. Children's is enrolling for Cohort F for patients with metastatic, refractory or unresectable malignant peripheral nerve sheath tumors.
  • Malignant peripheral nerve sheath tumor
  • Ages ≥ 12 years
Ascentage Pharma Group Inc.AeRang Kim, M.D.Malignant peripheral nerve sheath tumor
Pivotal/Phase II Clinical Trial of Magnetic Resonance-Guided Focused Ultrasound (MR-HIFU) Treatment of Painful Osteoid Osteoma in Children and Young Adults
NCT04658771
A Phase 2 study to determine treatment safety and efficacy of MR-HIFU ablation of painful osteoid osteoma in children and young adults.
  • Painful osteoid osteoma
  • Ages ≤ 30 years
Children's National Hospital Karun Sharma, M.D.Osteoid osteoma
ADVL1921: Phase 1 study to evaluate the safety and pharmacokinetics of Palbociclib (Ibrance®) in combination with Irinotecan and Temozolomide and in combination with Topotecan and Cyclophosphamide in pediatric patients with recurrent or refractory solid tumors
NCT03709680
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
  • Recurrent/refractory solid tumors, including CNS tumors
  • Age ≥ 2 to < 21 years
Pfizer AeRang Kim, M.D.All solid tumors, CNS
PNOC-013: A Safety and Pharmacokinetic Study of Single Agent REGN2810 in Pediatric Patients With Relapsed or Refractory Solid or Central Nervous System (CNS) Tumors and a Safety and Efficacy Trial of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Newly Diagnosed High-Grade Glioma, or Recurrent High-Grade Glioma
NCT03690869
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.
  • 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
Pacific Neuro-Oncology ConsortiumLindsay Kilburn, M.D.Diffuse intrinsic pontine glioma, high grade glioma, recurrent high grade glioma, solid tumors
EH102: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
NCT02601937
This is a phase 1 study of Tazemetostat for patients with INI1 negative tumors of CNS or rhabdoid solid tumors.
  • Relapsed/refractory disease of malignant rhabdoid tumors, including CNS
  • Ages > 6 months to < 18 years
EpizymeLindsay Kilburn, M.D.Rhabdoid tumors, INI1 negative tumors includes CNS tumors
OZM-077: Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain and Solid Tumors
NCT03206021
Phase 1/1b study of the combination of azacitidine and carboplatin for CNS ependymomas and childhood solid tumors.
  • Recurrent/refractory brain or solid tumor including recurrent/refractory ependymomas
  • Tissue from diagnosis or resection is required
  • Ages 1 to < 18 years
The Hospital for Sick Children Eugene Hwang, M.D.CNS ependymoma, solid tumors
VAL-10-001: Pilot Pharmacokinetic Study of VAL-413 (Orotecan®) in Patients with Recurrent Pediatric Solid Tumors
NCT04337177

 

 

 

 
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
  • Recurrent Pediatric Solid Tumors
  • ≥ 1 year of age or ≤ 30 years of age
Valent Technologies LLCAeRang Kim, M.D.Solid tumors, including CNS tumors  
JZP712-101: A Phase 1/2 Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
NCT05734066

 

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
 
  • 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.
Jazz PharmaceuticalsAeRang Kim, M.D.Solid tumors
J20112: Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor
NCT04465643
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
  • 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
 
Johns Hopkins University School of MedicineAeRang Kim, M.D.ANNUBP, low grade MPNST or high grade MPNST