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CP-675, 206 and gemcitabine

Phase 1

Pancreatic Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 6, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

CP-675, 206 and gemcitabine · 1 trial · 1 indication

Phase 1 1
NCT00556023A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic CancerPancreatic Cancer
COMPLETED37 Analytics
PHASE1COMPLETED
A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicities: assessed through adverse event data collected weekly
8 week intervals

Secondary Endpoints

HAHA Response to CP-675,206:
12 months
Lymphocyte Subset Analysis:
12 months
Cytokine Analysis:
12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CP-675,206 and gemcitabineEXPERIMENTAL -

Interventions

NameTypeDescription
CP-675,206 and gemcitabineDRUGEscalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients with metastatic pancreatic cancer * Patient must have adequate bone marrow, liver and kidney function * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 * Chemotherapy naive * Inoperable pancreatic cancer Exclusion Criteria: ...

Countries:CanadaItaly
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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 CP-675, 206 and gemcitabine

What is CP-675,206 used for?

CP-675,206 is an investigational oncology therapy being studied in prostatic neoplasms, melanoma, pancreatic cancer, renal cell carcinoma, non-small-cell lung cancer, and colorectal neoplasms. It is a small molecule being developed by AstraZeneca PLC and is currently in Phase 2 clinical development.

What does CP-675,206 target?

CP-675,206 is a small molecule oncology therapy. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated across multiple solid tumor types including melanoma, renal cell carcinoma, and non-small-cell lung cancer.

Who makes CP-675,206?

CP-675,206 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical trials for multiple oncology indications.

What phase is CP-675,206 in?

CP-675,206 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, along with two Phase 1 trials, with a total enrollment of 740 patients across all studies.

What clinical trials is CP-675,206 in?

CP-675,206 has completed two Phase 2 trials: NCT00086489 in advanced melanoma and NCT00312975 in non-small-cell lung cancer. Two Phase 1 trials, NCT00372853 in metastatic renal cell carcinoma and NCT00431275 in melanoma, have also been completed. All trials are closed.

Is CP-675,206 the same as tremelimumab?

CP-675,206 is an investigational monoclonal antibody being developed by AstraZeneca. While it has been studied in oncology indications, no alternative names have been established in the clinical trial records. The drug remains in Phase 2 development.