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autologous human tumor-derived HSPPC-96

Phase 3

Renal Cell Carcinoma | Small molecule | Oncology |Agenus Inc.|Trials Updated: Sep 28, 2023

autologous human tumor-derived HSPPC-96 development status

Highest phase Phase 3
Registered trials 3 across 1 sponsor since Apr 2002

autologous human tumor-derived HSPPC-96 target and mechanism

Molecular targetADA
Target classExogenous Gene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment685

FDA Designations

No designations recorded

autologous human tumor-derived HSPPC-96 clinical trials

autologous human tumor-derived HSPPC-96 · 2 trials · 3 indications

Phase 3 1Phase 2 1
NCT00033904Survival Study Of Oncophage® vs. Observation In Patients With Kidney CancerRenal Cell Carcinoma
COMPLETED650 Analytics
PHASE3COMPLETED
Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
Renal Cell CarcinomaUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
autologous human tumor-derived HSPPC-96DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites76

Pre-Surgery Inclusion Criteria: * Primary-intact resectable renal cell cancer, without known distant metastasis and be scheduled to have surgery with curative intent; * Tumor size greater than or equal to 5 cm OR macroscopic nodes OR renal vein thrombus OR vena cava thrombus by radiologic evaluatio...

Countries:United StatesAustriaBelgiumCanadaFranceIsraelNorwayPolandSpainSwedenUnited Kingdom
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Frequently asked questions about autologous human tumor-derived HSPPC-96

What is autologous human tumor-derived HSPPC-96 used for?

Autologous human tumor-derived HSPPC-96 is an investigational cancer vaccine developed for follicular lymphoma and renal cell carcinoma. It has been studied in indolent lymphoma, including small lymphocytic lymphoma, and in kidney cancer. It is not an approved therapy and remains in clinical development.

What does autologous human tumor-derived HSPPC-96 target?

Autologous human tumor-derived HSPPC-96 targets ADA, classified as an exogenous gene target. This target is the molecular focus of the agent as recorded in its drug profile. The vaccine is designed as a patient-specific treatment derived from the individual's own tumor material.

Who is developing autologous human tumor-derived HSPPC-96?

Agenus Inc., which trades under the ticker AGEN, is the developer of autologous human tumor-derived HSPPC-96. The company has advanced the agent through clinical testing in oncology indications, including lymphoma and renal cell carcinoma.

What phase is autologous human tumor-derived HSPPC-96 in?

Autologous human tumor-derived HSPPC-96 is in Phase 2 development. It is an investigational agent and has not been approved by the FDA. A completed Phase 3 trial in renal cell carcinoma also exists, but the drug's current listed development stage is Phase 2.

What clinical trials is autologous human tumor-derived HSPPC-96 in?

Autologous human tumor-derived HSPPC-96 has been studied in two completed trials: NCT00081809, a Phase 2 safety and effectiveness study in indolent lymphoma with 35 patients, and NCT00033904, a Phase 3 survival study versus observation in kidney cancer with 650 patients across multiple countries.

Is autologous human tumor-derived HSPPC-96 the same as Oncophage?

Yes, autologous human tumor-derived HSPPC-96 is also known as Oncophage. The Phase 3 renal cell carcinoma trial NCT00033904 was titled as a survival study of Oncophage versus observation. Both names refer to the same investigational agent developed by Agenus Inc.