First In Human Study of CX-801 in Advanced Solid Tumors

NCT06462794
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
121
clinicaltrials.gov
Lead sponsor
CytomX Therapeutics
clinicaltrials.gov
Start date
2024-08-28
clinicaltrials.gov
Number of sites
5
clinicaltrials.gov

Summary
The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.
clinicaltrials.gov
Short title
First In Human Study of CX-801 in Advanced Solid Tumors
clinicaltrials.gov
Official title
An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2029-06-30
clinicaltrials.gov
First posted
2024-06-17
clinicaltrials.gov
Registry last updated
2026-08-28
clinicaltrials.gov
Primary completion date
2028-02-28
clinicaltrials.gov
Start date
2024-08-28
clinicaltrials.gov

Participants
121
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
121
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
5
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
CytomX Therapeutics
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06462794
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06462794
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Safety and tolerability of CX-801 as monotherapy and combination therapy

    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. 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.

  5. 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.

  6. 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
  • Adequate organ function
  • 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
  • Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event
  • Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
  • Investigational drug or device within 4 weeks prior to first dose of study treatment
  • Radiation within 2 weeks prior to first dose of study treatment
  • Serious concurrent illness
  • Pregnant or breast feeding
  • Additional exclusion criteria may apply
Sources for eligibility
clinicaltrials.gov

  • The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos Angeles, United StatesRecruiting
  • The Melanoma and Skin Cancer InstituteEnglewood, United StatesRecruiting
  • University of Pittsburgh Hillman Cancer CenterPittsburgh, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • START Dallas Fort Worth, LLCFort Worth, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • KEYNOTE-F95
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (1)