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Endoxana, IMA901, Leukine

Phase 2

Renal Cell Carcinoma | Small molecule | Oncology |Immatics N.V.|Last Updated: Jul 10, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

Endoxana, IMA901, Leukine · 1 trial · 1 indication

Phase 2 1
NCT00523159IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable DiseaseRenal Cell Carcinoma
COMPLETED68 Analytics
PHASE2COMPLETED
IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease
Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease control rate
after 26 weeks

Secondary Endpoints

Tumor response rates and SD rate
after 26 and 38 weeks
Duration of response
from the time response is first documented until the first date of recurrence or PD
Time to response
From Visit c to PR or CR
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1OTHERPre-treatment with a single low dose of Cyclophosphamide followed by IMA901 vaccination plus GM-CSF as adjuvant
2OTHERNo pre-treatment with Cyclophosphamide before vaccination with IMA901 and GM-CSF as adjuvant

Interventions

NameTypeDescription
Endoxana, IMA901, LeukineDRUGa single i.v. infusion of Cyclophosphamid and then patients received vaccination therapy with intradermal (i.d.) injections of GM-CSF followed by i.d. injections of IMA901
IMA901 and LeukineDRUGIntradermal injection of GM-CSF followed by intradermal injection of IMA901
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Aged at least 18 years * HLA type: HLA-A\*02-positive * Histologically documented advanced clear-cell RCC * Patients who have received first-line tyrosine kinase inhibitor or cytokine systemic therapy for advanced disease systematic therapy for advanced disease and must be can...

Countries:AustriaBulgariaGermanyHungaryPolandRomaniaSlovakiaSpainSwitzerlandUnited Kingdom
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Frequently asked questions about Endoxana, IMA901, Leukine

What is Endoxana used for?

Endoxana is a small molecule oncology drug being studied for use in renal cell carcinoma and colorectal carcinoma. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being developed by Immatics N.V., a biopharmaceutical company focused on cancer treatments.

What does Endoxana target?

Endoxana is a small molecule therapeutic being investigated for the treatment of renal cell carcinoma and colorectal carcinoma. The specific molecular target of Endoxana has not been disclosed in available clinical trial information. It is currently in Phase 2 development for these oncology indications.

Who makes Endoxana?

Endoxana is being developed by Immatics N.V., a biopharmaceutical company listed on the stock exchange under the ticker symbol IMTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with renal cell carcinoma and colorectal carcinoma.

What phase is Endoxana in?

Endoxana is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of renal cell carcinoma and colorectal carcinoma, with clinical trials ongoing to assess its potential as a cancer therapy.

What clinical trials is Endoxana in?

Endoxana has been studied in clinical trials including NCT00523159, a Phase 2 trial in advanced renal cell carcinoma with 68 participants, and NCT00785122, a Phase 1 trial in colorectal carcinoma with 92 participants. Both trials have been completed. The trials were conducted across multiple European countries.

Is Endoxana the same as IMA901?

Endoxana is also known as IMA901 and Leukine. These names refer to the same drug product being developed by Immatics N.V. The drug has been evaluated under different names in clinical trials for renal cell carcinoma and colorectal carcinoma indications.