First In Human Study of CX-2051 in Advanced Solid Tumors

An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors

The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult subjects with advanced solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: CX-2051

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. Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 in indication-specific expansion cohorts.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Karen Deane; Phone Number: 650-515-3185; Email: clinicaltrials@cytomx.com

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CX-2051	Drug: CX-2051; Investigational drug monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of CX-2051	The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level	44 months
Determine the recommended Phase 2 dose (RP2D)	The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level	44 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	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	60 months
Duration of response (DOR)	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.	60 months
Progression-free survival (PFS)	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.	60 months
Disease control rate (DCR)	DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.	60 months
Duration of disease control (DODC)	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.	60 months
Overall survival (OS)	OS defined as the time from the first dose of study intervention to death due to any cause	60 months

Collaborators and Investigators

• Sponsor: CytomX Therapeutics
• Investigators: Study Director: Monika Vainorius, MD, CytomX Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CTMX-2051-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No