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Oncology/Rhabdomyosarcoma

Rhabdomyosarcoma

36

Pipeline Programs↗

18

Active Trials↗

15

Companies Involved↗

Rhabdomyosarcoma is a moderately active landscape with 36 programs across 15 companies. 12 programs are in Phase 3.

Intelligence

Pipeline Metrics

Competitive Density

57/100

Pipeline Velocity

15/100

Mech. Concentration

24/100

Completion Rate

83/100

Attrition Rate

9/100

Pipeline

Programs by Phase

Preclinical

No programs

Phase 13

Personalized Neoantigen MRNA Vaccine

Xinxin Zhang

Mocetinostat

Mirati Therapeutics Inc.

MRNA Tumor Vaccine Therapy

Xinxin Zhang

Phase 221

Sorafenib

Bayer

Temozolomide

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Bevacizumab

Roche

Doxorubicin

Pfizer

Irinotecan

Pfizer

Phase 312

Dactinomycin

RECORDATI GROUP

Cyclophosphamide

Baxter Healthcare Corporation

Vincristine Sulfate

Eli Lilly

Irinotecan Hydrochloride

Pfizer

Carboplatin

Avyxa

Approved

No programs

Analysis

Modality Breakdown

88%

Small molecule

30 of 34 classified programs — the dominant modality here.

Small molecule leads; the ring shows all 34 classified programs, each share of the total. Modality classified for 97% of 36 pipeline programs.

Analysis

Trial Status

46

clinical trials

Completed19 · 41%

Recruiting9 · 20%

Active, not recruiting7 · 15%

Unknown status5 · 11%

Terminated2 · 4%

Withdrawn2 · 4%

Other2 · 4%

Clinical Trials

Trial Activity

46 trials

Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma

Recruiting·—·Phase 1·NCT06932861·5 enrolled

Phase I Dose Escalation Study of FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma

Recruiting·National Cancer Institute (NCI)·Phase 1·NCT06865664·50 enrolled

A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma

Recruiting·Children's Oncology Group·Phase 3·NCT07466316·342 enrolled

A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

Recruiting·Children's Oncology Group·Phase 3·NCT05304585·205 enrolled

Selective Antigen Specific dTβRII-expressing T Cells and B7-H3 CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)

Recruiting·CChildren's National Research Institute·Phase 1·NCT07172958·18 enrolled

Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents

Recruiting·SShandong Cancer Hospital and Institute·Phase 2·NCT06816771·38 enrolled

Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of First Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Multicenter, Phase II Clinical Study

Recruiting·SSun Yat-sen University·Phase 2·NCT05457829·88 enrolled

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

Recruiting·UUniversity of Birmingham·Phase 1/2·NCT04625907·1,672 enrolled

Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06023641·135 enrolled

VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors: An Open-label, Phase II, Single-arm, Multi-center Trial

Active, not recruiting·UUniversity of Texas Southwestern Medical Center·Preclinical·NCT04796012·23 enrolled

A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Active, not recruiting·National Cancer Institute (NCI)·Phase 3·NCT02567435·325 enrolled

A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

Active, not recruiting·Children's Oncology Group·Phase 3·NCT04994132·113 enrolled

A Phase I Dose Escalation/Expansion Clinical Trial of Mocetinostat in Combination With Vinorelbine in Children, Adolescents and Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma (RMS)

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 1·NCT04299113·14 enrolled

Evolutionary Therapy for Rhabdomyosarcoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT04388839·12 enrolled

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT01871766·115 enrolled

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Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)