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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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Frequently asked questions about CX-2009

What is CX-2009 used for?

CX-2009 is an investigational small molecule being developed for the treatment of neoplasms, specifically advanced breast cancer. It is being studied as a monotherapy and in combination with CX-072 in patients with conditions including triple-negative breast cancer and hormone receptor positive/HER2 negative breast cancer.

Who makes CX-2009?

CX-2009 is being developed by CytomX Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CTMX. The company is conducting clinical research to evaluate the safety and antitumor activity of this investigational therapy in advanced breast cancer.

What phase is CX-2009 in?

CX-2009 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy. The Phase 2 trial evaluating CX-2009 in advanced breast cancer has been completed.

What clinical trials is CX-2009 in?

CX-2009 has been studied in one clinical trial, identified as NCT04596150. This Phase 2 study evaluated the safety and antitumor activity of CX-2009 as a monotherapy and in combination with CX-072 in advanced breast cancer. The trial enrolled 125 participants and has been completed.

Is CX-2009 the same as CX-072?

No, CX-2009 and CX-072 are different investigational drugs. In the clinical trial NCT04596150, CX-2009 was studied both as a monotherapy and in combination with CX-072. The trial was designed to evaluate the safety and antitumor activity of CX-2009 alone and when combined with CX-072 in advanced breast cancer.