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NCT06462794 | RECRUITING | Solid Tumor, Adult

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

CytomX Therapeutics

Brief 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.

Condition or disease

Solid Tumor, Adult

Intervention/treatment

CX-801

pembrolizumab

Phase

PHASE1

Detailed Description:

The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.

Study Type : INTERVENTIONAL
Estimated Enrollment : 121 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
Actual Study Start Date : 2024-08-28
Estimated Primary Completion Date : 2028-02-28
Estimated Study Completion Date : 2029-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • * Adequate organ function
  • * 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
  • * Prior immunotherapy 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
First In Human Study of CX-801 in Advanced Solid Tumors

Location Details

NCT06462794

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

University of California San Francisco

San Francisco, California, United States, 94158

RECRUITING

United States, Pennsylvania

University of Pittsburgh Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232