Brief Summary
The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.
Brief Title
First In Human Study of CX-2051 in Advanced Solid Tumors
Detailed Description
The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051 as monotherapy and as combination therapy (CX-2051 combined with bevacizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 as monotherapy and/or combination therapy in indication-specific expansion cohorts.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
650-515-3185
Central Contact Email
clinicaltrials@cytomx.com
Completion Date
Completion Date Type
Estimated
Conditions
Solid Tumor, Adult
Eligibility Criteria
Inclusion Criteria:
* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Measurable disease per RECIST v1.1
* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
* Additional inclusion criteria may apply
Exclusion Criteria:
* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
* Known active central nervous system (CNS) involvement by malignancy
* Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1
* Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
* Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1
* Elevated baseline laboratory values
* Serious concurrent illness
* Pregnant or breast feeding
* Additional exclusion criteria may apply
* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Measurable disease per RECIST v1.1
* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
* Additional inclusion criteria may apply
Exclusion Criteria:
* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
* Known active central nervous system (CNS) involvement by malignancy
* Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1
* Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
* Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1
* Elevated baseline laboratory values
* Serious concurrent illness
* Pregnant or breast feeding
* Additional exclusion criteria may apply
Inclusion Criteria
Inclusion Criteria:
* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Measurable disease per RECIST v1.1
* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
* Additional inclusion criteria may apply
* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Measurable disease per RECIST v1.1
* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
* Additional inclusion criteria may apply
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06265688
Org Class
Industry
Org Full Name
CytomX Therapeutics
Org Study Id
CTMX-2051-101
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
Primary Outcomes
Outcome Description
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Outcome Measure
Safety and tolerability of CX-2051
Outcome Time Frame
44 months
Outcome Description
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Outcome Measure
Determine the recommended Phase 2 dose (RP2D)
Outcome Time Frame
44 months
Secondary Outcomes
Outcome Description
ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment
Outcome Time Frame
60 months
Outcome Measure
Objective response rate (ORR)
Outcome Description
DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Outcome Time Frame
60 months
Outcome Measure
Duration of response (DOR)
Outcome Description
PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Outcome Time Frame
60 months
Outcome Measure
Progression-free survival (PFS)
Outcome Description
TTF defined as the time from first dose of study intervention to the date of premature discontinuation for any reason, including tumor progression, severe toxicity, participant withdrawal, or death.
Outcome Time Frame
60 months
Outcome Measure
Time to Treatment Failure (TTF)
Outcome Description
DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.
Outcome Time Frame
60 months
Outcome Measure
Disease control rate (DCR)
Outcome Description
DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Outcome Time Frame
60 months
Outcome Measure
Duration of disease control (DODC)
Outcome Description
OS defined as the time from the first dose of study intervention to death due to any cause
Outcome Time Frame
60 months
Outcome Measure
Overall survival (OS)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Fernand Bteich
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
MeSH Terms
BEVACIZUMAB
ANTIBODIES, MONOCLONAL, HUMANIZED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
SERUM GLOBULINS
GLOBULINS