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Motixafortide

Phase 2

Pancreatic Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 19, 2025

Target and mechanism

Molecular targetCXCR4
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Motixafortide · 1 trial · 3 indications

Phase 2 1
NCT04543071Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic AdenocarcinomaPancreatic Cancer
RECRUITING10 Analytics
PHASE2RECRUITING
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Response Rate (Complete Response (CR) + Partial Response (PR))
16 weeks

Complete response is defined as the disappearance of all lesions. Partial response is defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.

Secondary Endpoints

Incidence of Treatment Related Toxicities
Up to 5 years
Median Overall Survival
Up to 5 years
Median Progression Free Survival
Up to 5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Motixafortide, Cemiplimab, Gemcitabine, Nab-PaclitaxelEXPERIMENTALParticipants will receive standard FDA-approved doses of gemcitabine and nab-paclitaxel for pancreas cancer and cemiplimab at the dose that is approved for participants with skin cancer. Participants will also receive motixafortide at a dose that has been deemed safe in previous studies when used in combination with immunotherapy and chemotherapy. If the combination study treatment causes a serious side effect in participants, the study treatment will be modified.

Interventions

NameTypeDescription
MotixafortideDRUG1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly
CemiplimabDRUG350 mg intravenous (IV) once every 21 days
GemcitabineDRUG1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)
Nab paclitaxelDRUG125 mg/m2 IV on days 1, 8, 14 (every 28 days)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: 1. Histological or pathological confirmation of metastatic pancreas adenocarcinoma 1. Cytologic or histologic proof of pancreas adenocarcinoma needs to be verified by the treating institution pathologist, either from the initial diagnostic biopsy or from the required pre-tre...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 179 trials

Top 20 of 68 competitors

CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD9PHASE3RMC-6236, Gemcitabine, nab-paclitaxel, Irinotecan, Liposomal irinotecan
Arcus Biosciences, Inc.RCUS3PHASE3Quemliclustat, Nab-paclitaxel, Gemcitabine
Pfizer Inc.PFE7PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin
AstraZeneca PLCAZN9PHASE2AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine
AngioDynamics, Inc.ANGO2PHASE3Modified FOLFIRINOX Regimen
Bristol-Myers Squibb CompanyBMY4PHASE2Navlimetostat, Gemcitabine, Nab-paclitaxel
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib, GnP, mGnP
RenovoRx, Inc.RNXT1PHASE3Gemcitabine, nab-paclitaxel
BioNTech SE Sponsored ADRBNTX2PHASE2Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822
Merck & Co., Inc.MRK2PHASE2Belzutifan
Eli Lilly and CompanyLLY7PHASE1LY4101174
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
Agenus Inc.AGEN4PHASE2AGEN1423, Botensilimab, Gemcitabine, Nab-paclitaxel
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
ImmunityBio IncIBRX1PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
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Frequently asked questions about Motixafortide

What is Motixafortide used for in Pancreatic Cancer?

Motixafortide is an investigational small molecule being studied for the treatment of pancreatic cancer, specifically pancreatic adenocarcinoma. It is currently in Phase 2 clinical development as a combination therapy with immunotherapy and chemotherapy. The drug is being evaluated in a clinical trial for patients with this condition.

What does Motixafortide target?

Motixafortide is a peptide-based small molecule that targets chemokine receptors. It is being studied for its role in modulating the tumor microenvironment to enhance the effects of immunotherapy and chemotherapy in pancreatic cancer. The drug's mechanism involves inhibiting chemokine signaling, which may help improve treatment outcomes.

Who makes Motixafortide?

Motixafortide is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. Regeneron is conducting clinical trials to evaluate the drug's safety and efficacy in patients with pancreatic cancer.

What phase is Motixafortide in?

Motixafortide is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is recruiting patients to assess the combination of Motixafortide with immunotherapy and chemotherapy in pancreatic adenocarcinoma.

What clinical trials is Motixafortide in?

Motixafortide is being evaluated in a Phase 2 clinical trial with the identifier NCT04543071, titled "Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma." This trial is recruiting patients in the United States and aims to enroll 10 participants with pancreatic cancer.

Is Motixafortide the same as BL-8040?

Motixafortide is also known by the alternative name BL-8040. It is a peptide-based small molecule being developed by Regeneron Pharmaceuticals for the treatment of pancreatic cancer. The drug is currently in Phase 2 clinical trials, and no alternative names beyond BL-8040 have been disclosed.