Study of XB010 in Subjects With Solid Tumors

Part of paid clinical trials in Irvine, California.

Sponsor
Exelixis
Study ID
NCT06545331
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Esophageal Squamous Cell Cancer
  • Head and Neck Squamous Cell Cancer
  • Hormone-receptor-positive Breast Cancer
  • Locally Advanced or Metastatic Solid Tumors
  • NSCLC (Non-small Cell Lung Cancer)
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XB010 — DRUG
    IV administration of XB010
  • Pembrolizumab — DRUG
    IV administration of Pembrolizumab

Study Details

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

Key Dates

First listed
Aug 9, 2024
Start date
Aug 6, 2024
Status verified
Jun 2026
Primary completion
Nov 23, 2026
Completion
Oct 20, 2027

Study Design

Enrollment
396 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: XB010 Single-Agent Dose Escalation Cohorts
    XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
  • Experimental: XB010 + Pembrolizumab Dose Escalation Cohorts
    XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
  • Experimental: XB010 Single-Agent Dose Expansion Cohorts
    XB010 will be administered at the recommended dose for expansion (RDE) every 3 weeks in the following tumor-specific cohorts: non-small cell lung cancer (NSCLC), hormone-receptor-positive breast cancer (HR+BC), head and neck squamous cell cancer (HNSCC), esophageal squamous cell cancer (ESCC), endometrial cancer (EC) and triple-negative breast cancer (TNBC)

Primary Outcome Measure

Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 [ Time Frame: 18 months ]

Central Contacts

  • Exelixis Clinical Trials
    1-888-EXELIXIS (888-393-5494)
    [email protected]
  • Backup or International
    650-837-7400

Locations (16)

FacilityCityStateZIPSite coordinators
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia91010-
UCLA Department of Medicine - Hematology/OncologyLos AngelesCalifornia90095-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827-
Winship Cancer InstituteAtlantaGeorgia30322-
University of Chicago Medical CenterChicagoIllinois60637-
Siteman Cancer CenterSt LouisMissouri63110-
Montefiore Medical Center - Montefiore Medical ParkThe BronxNew York10461-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
SCRI Oncology PartnersNashvilleTennessee37203-
NEXT AustinAustinTexas78758-
Baylor University Medical CenterDallasTexas75246-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Inova Schar CancerFairfaxVirginia22031-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Irvine, CA

By research site
City of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAUCLA Department of Medicine - Hematology/Oncology· Los Angeles, CAGeorgetown University Medical Center· Washington D.C., DCSarah Cannon Research Institute at Florida Cancer Specialists· Orlando, FLWinship Cancer Institute· Atlanta, GAUniversity of Chicago Medical Center· Chicago, IL

Related Studies