Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

Phase 2

Completed

• Conditions: Neoplasms; Breast Neoplasms; Breast Cancer; Breast Neoplasms, Triple-Negative; Breast Neoplasms, Hormone Receptor Positive/HER2 Negative
• Interventions: Drug: CX-2009; Drug: CX-072

• Registration Number: NCT04596150
• Lead Sponsor: CytomX Therapeutics

Brief Summary

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

Detailed Description

Eligible patients will be enrolled to the treatment arm based on breast cancer subtype.

Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009 monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until disease progression or symptomatic deterioration, unacceptable toxicity necessitating treatment discontinuation, or if the patient meets certain study defined criteria for discontinuation. On-treatment tumor assessments, will occur every 6 weeks per RECIST v1.1 for the first 48 weeks, and every 12 weeks thereafter.

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Start: 2020-12-29
• Primary Completion: 2023-06-02
• Study Completion: 2023-06-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM C - CX-2009 Combination therapy, TNBC	CX-072	CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative	CX-2009	CX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer
ARM B - CX-2009 Monotherapy, TNBC	CX-2009	CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)
ARM C - CX-2009 Combination therapy, TNBC	CX-2009	CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical Benefit Rate (CBR) at 16 Weeks	30 Months	This will include sum of confirmed Complete plus Partial Responses plus stable disease at 16 weeks on treatment
Duration of Response (DoR)	30 Months	The time that measurement criteria are met for CR or PR (based on RECIST v1.1) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started)
Overall Survival (OS)	30 Months	The time from treatment initiation until death as a result of any cause
Clinical Benefit Rate (CBR) at 24 Weeks	30 Months	This will include sum of confirmed Complete plus Partial Responses plus stable disease at 24 weeks on treatment
Investigator-assessed Progression-Free Survival (PFS)	30 Months	The time from the date of the first dose of study treatment until documentation of objective tumor progression based on RECIST v1.1 or until death due to any cause

Trial Locations

Locations (42)

Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Los Angeles Hematology Oncology Medical; 🇺🇸 Los Angeles, California, United States

USC Norris Cancer Center; 🇺🇸 Los Angeles, California, United States

UCLA David Geffen; 🇺🇸 Santa Monica, California, United States

Rocky Mountain Cancer Centers; 🇺🇸 Lone Tree, Colorado, United States

FCS - South; 🇺🇸 Fort Myers, Florida, United States

Baptist Medical Center; 🇺🇸 Jacksonville, Florida, United States

Hematology Oncology Assoc of the Treasure Coast; 🇺🇸 Port Saint Lucie, Florida, United States

FCS - North; 🇺🇸 Saint Petersburg, Florida, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

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