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CX-2009

Phase 2

Neoplasms | Small molecule | Oncology |CytomX Therapeutics, Inc.|Last Updated: Jan 23, 2024

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment125
FDA Designations
No designations recorded
Clinical trial landscape

CX-2009 · 1 trial · 5 indications

Phase 2 1
NCT04596150Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast CancerNeoplasms
COMPLETED125 Analytics
PHASE2COMPLETED
Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
NeoplasmsUnlock trial analytics
Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
30 months

ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Central Radiology Review (CRR)

Secondary Endpoints
Investigator-assessed Progression-Free Survival (PFS)
30 Months
Duration of Response (DoR)
30 Months
Overall Survival (OS)
30 Months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARM A - CX-2009 Monotherapy, HR-positive/HER2-negativeEXPERIMENTALCX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer
ARM B - CX-2009 Monotherapy, TNBCEXPERIMENTALCX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)
ARM C - CX-2009 Combination therapy, TNBCEXPERIMENTALCX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
Interventions
NameTypeDescription
CX-2009DRUGIntravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)
CX-072DRUGIntravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W)
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

INCLUSION CRITERIA: * Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the inoperable, locally advanced, or metastatic setting * Arm B and Arm C: inoperable, locally advanced or metastatic T...

Countries:United StatesSouth KoreaSpain
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