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Endoxana, Leukine, IMA910

Phase 1

Colorectal Carcinoma | Small molecule | Oncology |Immatics N.V.|Last Updated: May 16, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

Endoxana, Leukine, IMA910 · 1 trial · 1 indication

Phase 1 1
NCT00785122IMA910 Plus GM-CSF With Low-dose Cyclophosphamide Pre-treatment in Advanced Colorectal Carcinoma Patients Following a Successful 12 Week First-line Treatment With Oxaliplatin-based Chemotherapy (IMA910-101)Colorectal Carcinoma
COMPLETED92 Analytics
PHASE1COMPLETED
IMA910 Plus GM-CSF With Low-dose Cyclophosphamide Pre-treatment in Advanced Colorectal Carcinoma Patients Following a Successful 12 Week First-line Treatment With Oxaliplatin-based Chemotherapy (IMA910-101)
Colorectal CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease control rate
after 27 weeks of vaccination
Safety assessment
continuously

Safety assessment with special emphasis on the inclusion of the first 6 patients enrolled according to a pre-specified enrolment plan

Secondary Endpoints

Tumour response rates and SD rate
after 27 and 37 weeks
DCR
after 37 weeks on study
Duration of response
till End of Study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Endoxana, Leukine, IMA910DRUGa single i.v. infusion of 300 mg/m2 Endoxana (Cyclophosphamide) and then 3 days later (visit 1) patients will start vaccination therapy with intradermal (i.d.) injections of 75µg GM-CSF followed by i.d. injections of 5.78 mg IMA90
Endoxana, Leukine, IMA910, AldaraDRUGa single i.v. infusion of 300 mg/m2 Endoxana (Cyclophosphamide) and then 3 days later (visit 1) patients will start vaccination therapy with intradermal (i.d.) injections of 75µg GM-CSF followed by i.d. injections of 5.78 mg IMA90 followed by Aldara (Imiquimod)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion criteria: * Aged at least 18 years * HLA type: HLA-A\*02-positive * Histologically confirmed colorectal adenocarcinoma (CRC) * Radiological evidence (CT/MRI) of unresectable locally advanced and/or metastatic CRC prior to 12 week first-line oxaliplatin-based standard chemotherapy * 12 wee...

Countries:BelgiumBulgariaGermanyHungaryLatviaPolandRomaniaSerbiaUnited Kingdom
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Frequently asked questions about Endoxana, Leukine, IMA910

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.