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recombinant interleukin-21

Phase 2

Cancer | Small molecule | Oncology |Novo Nordisk A/S|Trials Updated: Aug 14, 2023

recombinant interleukin-21 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Jun 2006

recombinant interleukin-21 target and mechanism

Molecular targetF9
Target classExogenous Protein
ModalitySmall molecule

Also known as rIL-21, NN028

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials3
Total Enrollment73

FDA Designations

No designations recorded

recombinant interleukin-21 clinical trials

recombinant interleukin-21 · 3 trials · 4 indications

Phase 2 3
NCT00523380Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian CancerCancer
COMPLETED10 Analytics
NCT00617253Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma PatientsCancer
COMPLETED9 Analytics
NCT00336986Efficacy Study of IL-21 to Treat Metastatic MelanomaCancer
COMPLETED54 Analytics
PHASE2COMPLETED
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
CancerUnlock trial analytics
PHASE2COMPLETED
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
CancerUnlock trial analytics
PHASE2COMPLETED
Efficacy Study of IL-21 to Treat Metastatic Melanoma
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
after max. 6 treatment cycles
Toxicity according to CTCAE version 3.0
For the duration of the trial
Tumor size assessed according to international criteria
After 8 weeks

Secondary Endpoints

Pharmacokinetics
Initially
IL-21 antibody formation
For the duration of the trial
Progression free survival
For the duration of the trial
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL -
DEXPERIMENTAL -

Interventions

NameTypeDescription
recombinant interleukin-21DRUGAdministered i.v. in treatment cycles of 28 days.
caelyx (pegylated liposomal doxorubicin)DRUGAdministered i.v. in treatment cycles of 28 days.
sunitinibDRUGHard gelatine capsules, 12.5 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Advanced epithelial Ovarian Cancer (stage IIB-IV) * Persistent or progressive disease after or relapse within one year of completion of first line therapy * Measurable or assessable disease * Eastern Cooperative Oncology Group status less than or equal to 2 Exclusion Criteria...

Countries:FranceGermanyNetherlandsAustralia
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about recombinant interleukin-21

What is recombinant interleukin-21 used for?

Recombinant interleukin-21 is an investigational cancer therapy studied in several tumor types. Phase 2 trials have evaluated it in metastatic melanoma, ovarian cancer, and renal cell carcinoma, including a combination study with sunitinib in stage IV renal cell carcinoma. It is not approved and remains in clinical development.

How does recombinant interleukin-21 work?

Recombinant interleukin-21 is an exogenous protein designed to act on the F9 target. As a recombinant form of the cytokine interleukin-21, it is given as a therapeutic protein rather than a conventional small molecule drug. Its target class is classified as an exogenous protein in oncology development.

Who is developing recombinant interleukin-21?

Recombinant interleukin-21 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is the sponsor behind the clinical program evaluating the agent in cancer indications.

What phase is recombinant interleukin-21 in?

Recombinant interleukin-21 is in Phase 2 development. All three of its recorded trials are Phase 2 studies, and all three are completed, with no active trials currently listed. It is an investigational agent and has not been approved for any indication.

What clinical trials is recombinant interleukin-21 in?

Three completed Phase 2 trials have studied recombinant interleukin-21: NCT00617253 combined it with sunitinib in stage IV renal cell carcinoma, NCT00523380 evaluated it in ovarian cancer, and NCT00336986 tested it in metastatic melanoma. Together these trials enrolled 73 patients across Germany, the Netherlands, France, and Australia.