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SBP-101

Phase 2/3

Pancreatic Cancer Metastatic | Small Molecules | Oncology |Panbela Therapeutics, Inc.|Trials Updated: Nov 6, 2024

SBP-101 development status

Highest phase Phase 2/3
Registered trials 3 across 1 sponsor since Jan 2016

SBP-101 target and mechanism

ModalitySmall Molecules

Also known as ivospemin, diethyl dihydroxyhomospermine, [(HO)2-DEHSPM]

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment679

FDA Designations

No designations recorded

SBP-101 clinical trials

SBP-101 · 3 trials · 6 indications

Phase 2/3 1Phase 1 2
NCT05254171Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic CancerPancreatic Cancer Metastatic
RECRUITING600 Analytics
PHASE2/PHASE3RECRUITING
Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
Pancreatic Cancer Metastatic
NCT05254171600
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Study Endpoints

Primary Endpoints

Overall Survival (OS)
From date of first dose up to 100 weeks or until death

Compare OS between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine

Recommended dose of SBP-101
Up to 12 months following the first dose of treatment
Maximum tolerated dose of SBP-101
Up to 18 months following the first dose of treatment

Secondary Endpoints

Progression Free Survival (PFS)
From date of first dose up to 100 weeks or until death
Number of subjects with adverse events as a measure of safety and tolerability
Up to 24 months following the first dose of treatment
Tumor response will be evaluated on RECIST definitions
Every 8 weeks during treatment assessed up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental ArmEXPERIMENTALSBP-101 + Nab-paclitaxel and Gemcitabine
Control ArmPLACEBO_COMPARATORPlacebo + Nab-Paclitaxel and Gemcitabine
SBP-101EXPERIMENTALSBP-101 is administered as a subcutaneous injection once daily, Monday through Friday for 3 weeks (total of 15 doses) followed by a 5-week rest period (3 weeks on, 5 weeks off = 1 treatment cycle). Dose escalation in phase 1a will continue until the maximum tolerated dose is determined.

Interventions

NameTypeDescription
SBP-101DRUGsmall molecule polyamine metabolic inhibitor for subcutaneous injection
Nab-paclitaxelDRUGpaclitaxel protein-bound particles for injectable suspension
GemcitabineDRUGgemcitabine for injection
PlaceboOTHERNormal Saline
Gemcitabine InjectionDRUGAdministered as intravenous (IV) infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites93

Inclusion Criteria: * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. * Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard t...

Countries:United StatesAustraliaAustriaBelgiumFranceGermanyItalySouth KoreaSpainUnited Kingdom
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Competitive Landscape -Pancreatic Cancer 247 trials (matched to "Pancreatic Cancer Metastatic")

Top 20 of 70 competitors

CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD12PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Bristol-Myers Squibb CompanyBMY6PHASE3Navlimetostat, Nab-paclitaxel, Nivolumab, BMS-986340, Pumitamig
Pfizer Inc.PFE8PHASE3Ponsegromab, tisotumab vedotin, PF-07934040, Bevacizumab, Sasanlimab
AbbVie, Inc.ABBV5PHASE3Telisotuzumab Adizutecan, ABBV-400, Azirkitug, Budigalimab, ABBV-253
Arcus Biosciences, Inc.RCUS2PHASE3Quemliclustat, Zimberelimab, Etrumadenant
Eli Lilly and CompanyLLY7PHASE2LY3537982, Cetuximab, Pemetrexed, LY4101174, LY4066434
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE3Surufatinib
AstraZeneca PLCAZN9PHASE2AZD4360, AZD5305, Trastuzumab deruxtecan, Dato-DXd, Camizestrant
Exelixis, Inc.EXEL1PHASE3Zanzalintinib
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib
Merck & Co., Inc.MRK4PHASE2Sacituzumab tirumotecan, Pembrolizumab, Belzutifan, Patritumab Deruxtecan
GE Healthcare Technologies Inc.GEHC1PHASE3GEH300079
BioNTech SE Sponsored ADRBNTX2PHASE2Autogene cevumeran, Pumitamig
Verastem, Inc.VSTM3PHASE2Avutometinib, VS-7375, Defactinib
Novartis AG Sponsored ADRNVS3PHASE2Spartalizumab, 68Ga-NNS309, Lu-NNS309, 177Lu-DFC413
Agenus Inc.AGEN4PHASE2AGEN1423, Botensilimab, Zalifrelimab, Balstilimab
Panbela Therapeutics, Inc.PBLA1PHASE3SBP-101
Genmab A/S Sponsored ADRGMAB1PHASE2GEN1042
Incyte CorporationINCY3PHASE2Ruxolitinib, Pemigatinib, Retifanlimab
Tango Therapeutics, Inc.TNGX1PHASE2TNG462
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