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Endoxana, Leukine, IMA910

Phase 2

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

Target and mechanism

ModalitySmall molecule

Also known as Endoxana, IMA901, Leukine

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, Leukine, IMA910 · 2 trials · 2 indications

Phase 2 1Phase 1 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
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

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
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 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 KingdomBelgiumLatviaSerbia
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Frequently asked questions about Endoxana, Leukine, IMA910

What is IMA910?

IMA910 is an investigational oncology therapy developed by Immatics N.V. (ticker IMTX) for advanced colorectal carcinoma. It was studied in a Phase 1 trial as a combination regimen with GM-CSF and low-dose cyclophosphamide pre-treatment in patients who had completed a successful 12-week first-line oxaliplatin-based chemotherapy regimen.

What is IMA910 used for in colorectal carcinoma?

IMA910 was evaluated in advanced colorectal carcinoma as a treatment following a successful 12-week first-line oxaliplatin-based chemotherapy regimen. The Phase 1 trial combined IMA910 with GM-CSF and low-dose cyclophosphamide pre-treatment. The study enrolled 92 patients across Belgium, Bulgaria, Germany, Hungary, Latvia, Poland, Romania, Serbia, and the United Kingdom.

Who is developing IMA910?

IMA910 is being developed by Immatics N.V., which trades under the ticker IMTX. The company is the sponsor of the clinical program investigating IMA910 in advanced colorectal carcinoma and IMA901 in renal cell carcinoma.

What phase is IMA910 in?

IMA910 is in Phase 1 clinical development. The Phase 1 trial, NCT00785122, evaluated IMA910 plus GM-CSF with low-dose cyclophosphamide pre-treatment in advanced colorectal carcinoma patients and has been completed. No active trials are currently listed for IMA910.

What clinical trials is IMA910 in?

IMA910 has been studied in one completed Phase 1 trial, NCT00785122, titled 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. The trial enrolled 92 patients across nine European countries and is no longer active.

Is IMA910 the same as IMA901?

No, IMA910 and IMA901 are distinct investigational agents. IMA910 was studied in advanced colorectal carcinoma in a Phase 1 trial, while IMA901 was studied in advanced renal cell carcinoma in a Phase 2 trial, NCT00523159, which enrolled 68 patients. Both were developed by Immatics N.V.