Recent Updates
Recently added Catalysts

CX-2009

Phase 2

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

CX-2009 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since May 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment125

FDA Designations

No designations recorded

CX-2009 clinical trials

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
Unlock Study Endpoints

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)
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about CX-2009

What is CX-2009?

CX-2009 is an investigational small molecule developed by CytomX Therapeutics, Inc. (ticker CTMX) for the treatment of neoplasms, including breast cancers. It has been studied as a monotherapy and in combination with CX-072 in patients with advanced breast cancer. CX-2009 is in Phase 2 clinical development and is not approved for commercial use.

What is CX-2009 used for in neoplasms?

CX-2009 is being studied for the treatment of neoplasms, with its clinical program focused on advanced breast cancer. The Phase 2 trial enrolled patients with triple-negative breast cancer and hormone receptor positive, HER2 negative breast cancer. It was evaluated both as a monotherapy and in combination with CX-072.

Who makes CX-2009?

CX-2009 is developed by CytomX Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol CTMX. CytomX is the sponsor of the clinical program evaluating CX-2009 in advanced breast cancer, including its Phase 2 study of CX-2009 alone and in combination with CX-072.

What phase is CX-2009 in?

CX-2009 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 program evaluated CX-2009 as monotherapy and in combination with CX-072 in patients with advanced breast cancer, and that trial has been completed.

What clinical trials is CX-2009 in?

CX-2009 has been evaluated in the Phase 2 trial NCT04596150, titled a study to evaluate the safety and antitumor activity of CX-2009 monotherapy and in combination with CX-072 in advanced breast cancer. The trial enrolled 125 patients across the United States, South Korea, and Spain and has been completed.

Was the CX-2009 trial randomized or blinded?

The Phase 2 trial of CX-2009, NCT04596150, was a controlled study but was not randomized and not double blinded. It enrolled 125 patients aged 18 years and older of all sexes, with no healthy volunteers, and evaluated CX-2009 monotherapy and CX-2009 in combination with CX-072 in advanced breast cancer.