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MMC in

Phase 2

Bladder Cancer | Small molecule | Oncology |UroGen Pharma Ltd.|Last Updated: Jun 16, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

MMC in · 1 trial · 4 indications

Phase 2 1
NCT02307487Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC PatientsBladder Cancer
COMPLETED14 Analytics
PHASE2COMPLETED
Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients
Bladder Cancer
NCT0230748714
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Study Endpoints

Primary Endpoints

Rate of Adverse Events (AE) findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Vital signs findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Clinical evaluation findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Lab results considered to be dose limiting according to the CTCAE V 4.0
6 weeks

Secondary Endpoints

Rates of all adverse events or clinically relevant physical examination
15 months
Vital signs and laboratory findings
15 months
MMC maximum plasma concentration and concentration time curve during 6 hr post instillation
15 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A2EXPERIMENTAL120 mg MMC in 90ml gel
Cohort B2EXPERIMENTAL140 mg MMC in 90ml gel
Cohort C2EXPERIMENTAL160 mg MMC in 90ml gel
Cohort AEXPERIMENTAL120 mg MMC in 60ml gel
Cohort BEXPERIMENTAL140 mg MMC in 60ml gel
Cohort CEXPERIMENTAL160 mg MMC in 60ml gel

Interventions

NameTypeDescription
120 mg MMC in 90ml gelDRUG120 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
140 mg MMC in 90ml gelDRUG140 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
160 mg MMC in 90ml gelDRUG160 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
120 mg MMC in 60ml gelDRUG120 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
140 mg MMC in 60ml gelDRUG140 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
160 mg MMC in 60ml gelDRUG160 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patient is 18 years of age or older. * Patient has signed Informed Consent Form and is willing and able to abide by the protocol. * Patients diagnosed with Low Grade (LG) or High grade (HG) NMIBC. * No active urinary tract infection as confirmed by urine culture. * If the pati...

Countries:Israel
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Competitive Landscape -Bladder Cancer 145 trials

Top 20 of 46 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN15PHASE3Durvalumab, Bacillus Calmette-Guerin
Bristol-Myers Squibb CompanyBMY5PHASE3Nivolumab, Gemcitabine, Cisplatin
Johnson & JohnsonJNJ12PHASE3TAR-200, Mitomycin C, Gemcitabine
Merck & Co., Inc.MRK14PHASE3Pembrolizumab, BCG
Pfizer Inc.PFE10PHASE3PF-06801591, Bacillus Calmette-Guerin
Eli Lilly and CompanyLLY4PHASE3Vepugratinib, EV, Pembrolizumab
Natera, Inc.NTRA2PHASE3Atezolizumab
UroGen Pharma Ltd.URGN4PHASE3UGN-103
CG Oncology, Inc.CGON2PHASE3Cretostimogene Grenadenorepvec
Protara Therapeutics, Inc.TARA2PHASE3TARA-002
Relmada Therapeutics IncRLMD2PHASE3NDV-01
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Tislelizumab, Cisplatin, Gemcitabine, Carboplatin
ImmunityBio IncIBRX6PHASE2N-803 and BCG
Exelixis, Inc.EXEL4PHASE2Cabozantinib, Atezolizumab
ICON PlcICLR1PHASE3padeliporfin VTP
Gilead Sciences, Inc.GILD2PHASE2Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab
Tyra Bioscience, IncTYRA3PHASE2Dabogratinib, Dabogratinib TBD
BioNTech SE Sponsored ADRBNTX1PHASE2Autogene Cevumeran, Nivolumab
AbbVie, Inc.ABBV1PHASE2Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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Frequently asked questions about MMC in

What is MMC in used for?

MMC in is an investigational small molecule being studied for the treatment of bladder cancer, specifically in patients with non-muscle invasive bladder cancer (NMIBC). It is administered as a pre-TURBT intravesical instillation, meaning it is delivered directly into the bladder before the surgical removal of tumors.

Who makes MMC in?

MMC in is being developed by UroGen Pharma Ltd., a biopharmaceutical company traded on NASDAQ under the ticker URGN. The company is focused on developing treatments for urological cancers.

What phase is MMC in in?

MMC in is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is still being evaluated in clinical trials to assess its safety and potential efficacy.

What clinical trials is MMC in in?

MMC in has been studied in one completed Phase 2 clinical trial, identified as NCT02307487. This trial, titled "Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients," enrolled 14 participants in Israel and evaluated the safety of the treatment.

Is MMC in the same as TC-3 gel?

MMC in is not the same as TC-3 gel. In the clinical trial NCT02307487, TC-3 gel is a separate investigational product being tested alongside MMC in. The trial evaluates the safety of escalating doses of both TC-3 gel and MMC when administered as intravesical instillations before TURBT.