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

NCT06265688
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
160
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Lead sponsor
CytomX Therapeutics
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Start date
2024-04-02
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Number of sites
8
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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.
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Short title
First In Human Study of CX-2051 in Advanced Solid Tumors
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Official title
An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-03-31
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First posted
2024-02-20
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Registry last updated
2026-07-15
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Primary completion date
2027-11-30
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Start date
2024-04-02
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Participants
160
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Participant count basis
Estimated
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Planned participants
160
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Protocol amendments
2
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Number of sites
8
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
CytomX Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06265688
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ClinicalTrials.gov ID
NCT06265688
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Safety and tolerability of CX-2051

    Timeframe: 44 months

    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

  2. Determine the recommended Phase 2 dose (RP2D)

    Timeframe: 44 months

    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

  1. Objective response rate (ORR)

    Timeframe: 60 months

    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

  2. Duration of response (DOR)

    Timeframe: 60 months

    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.

  3. Progression-free survival (PFS)

    Timeframe: 60 months

    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.

  4. Time to Treatment Failure (TTF)

    Timeframe: 60 months

    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.

  5. Disease control rate (DCR)

    Timeframe: 60 months

    DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.

  6. Duration of disease control (DODC)

    Timeframe: 60 months

    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.

  7. Overall survival (OS)

    Timeframe: 60 months

    OS defined as the time from the first dose of study intervention to death due to any cause

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Montefiore Medical CenterThe Bronx, United StatesRecruiting
  • Carolina BioOncology Institute, PLLCHuntersville, United StatesRecruiting
  • Sarah Cannon Research Institute, LLCNashville, United StatesRecruiting
  • START - Dallas/Fort WorthFort Worth, United StatesRecruiting
  • START San Antonio LLCSan Antonio, United StatesRecruiting
  • NEXT VirginiaFairfax, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)