Back to resultsA Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
Primary Purpose
Solid Tumors
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CX-904
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.
- Measurable disease per RECIST 1.1
- Patients with brain metastases that are ≤ 1 cm, are symptomatic, and require treatment may be eligible after discussion with Medical Monitor.
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate baseline laboratory values
- Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control from signing the ICF, and for a period of 30 days after the last dose of CX-904.
- Additional inclusion criteria may apply
Exclusion Criteria:
- History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator, present a low risk of recurrence
- Screening electrocardiogram demonstrating a mean QTcF value > 480 msec; a screening echocardiogram with left ventricular ejection fraction (LVEF) < 50%
Serious concurrent illness including
- History of or current active autoimmune diseases
- History of myocarditis regardless of the cause
- Pregnant or breast feeding
- Additional exclusion criteria may apply
Sites / Locations
- Sarah Cannon Research Institute, LLCRecruiting
- MD Anderson Cancer CenterRecruiting
- South Texas Accelerated Research Therapeutics, LLCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CX-904
Arm Description
Outcomes
Primary Outcome Measures
Patients Experiencing Dose-limiting Toxicity
The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.
Secondary Outcome Measures
Objective Response Rate (ORR)
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).
Duration of Response (DOR)
The time from the first documentation of CR or PR (based on RECIST v1.1) that is subsequently confirmed to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Investigator-assessed Progression-Free Survival (PFS)
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, whichever occurs first.
Disease Control Rate (DCR)
DCR is defined as the rate of confirmed CR, PR, and stable disease (SD) as per RECIST v1.1.
Overall Survival (OS)
The time from treatment initiation until death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05387265
Brief Title
A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
Official Title
A Phase 1/1b, Open-label, Dose-finding, First-in-human Study to Evaluate the Safety and Antitumor Activity of CX-904, an EGFR-targeted T-cell Engager in Advanced Solid Tumors (CTMX-904-101)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytomX Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this first-in-human study, CTMX-904-101, is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-904 in adult subjects with metastatic or locally advanced unresectable solid tumors.
Detailed Description
This is a first-in-human study evaluating the safety, tolerability, and activity of CX-904, a conditionally activated T-cell bispecific to EGFR and CD3. The design includes single patient cohorts and a 3+3 design. Escalating dose increments will be determined in discussion with a Safety Review Committee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CX-904
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CX-904
Intervention Description
CX-904 is a T-cell engaging bispecific Probody® candidate against Epidermal Growth Factor Receptor (EGFR) and CD3.
Primary Outcome Measure Information:
Title
Patients Experiencing Dose-limiting Toxicity
Description
The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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).
Time Frame
30 months
Title
Duration of Response (DOR)
Description
The time from the first documentation of CR or PR (based on RECIST v1.1) that is subsequently confirmed to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Time Frame
30 months
Title
Investigator-assessed Progression-Free Survival (PFS)
Description
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, whichever occurs first.
Time Frame
30 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the rate of confirmed CR, PR, and stable disease (SD) as per RECIST v1.1.
Time Frame
30 months
Title
Overall Survival (OS)
Description
The time from treatment initiation until death due to any cause.
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.
Measurable disease per RECIST 1.1
Patients with brain metastases that are ≤ 1 cm, are symptomatic, and require treatment may be eligible after discussion with Medical Monitor.
Eastern Cooperative Oncology Group performance status of 0 or 1
Adequate baseline laboratory values
Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control from signing the ICF, and for a period of 30 days after the last dose of CX-904.
Additional inclusion criteria may apply
Exclusion Criteria:
History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator, present a low risk of recurrence
Screening electrocardiogram demonstrating a mean QTcF value > 480 msec; a screening echocardiogram with left ventricular ejection fraction (LVEF) < 50%
Serious concurrent illness including
History of or current active autoimmune diseases
History of myocarditis regardless of the cause
Pregnant or breast feeding
Additional exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Ney
Phone
(650) 515-3185
Email
ClinicalTrials@CytomX.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Vainorius, M.D.
Organizational Affiliation
CytomX Therapeutics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Sarah Cannon Research Institute, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
South Texas Accelerated Research Therapeutics, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
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