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

Start date
Aug 6, 2024
Status verified
Apr 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 (15)

FacilityCityStateZIPSite coordinators
Exelixis Clinical Site #4IrvineCalifornia92618-
Exelixis Clinical Site #19Los AngelesCalifornia90095-
Exelixis Clinical Site #10Washington D.C.District of Columbia20007-
Exelixis Clinical Site #18OrlandoFlorida32827-
Exelixis Clinical Site #12AtlantaGeorgia30322-
Exelixis Clinical Site #15ChicagoIllinois60637-
Exelixis Clinical Site #5St LouisMissouri63110-
Exelixis Clinical Site #3HuntersvilleNorth Carolina28078-
Exelixis Clinical Site #6Oklahoma CityOklahoma73104-
Exelixis Clinical Site #9NashvilleTennessee37203-
Exelixis Clinical Site #1AustinTexas78758-
Exelixis Clinical Site #7DallasTexas74246-
Exelixis Clinical Site #8HoustonTexas77030-
Exelixis Clinical Site #11FairfaxVirginia22031-
Exelixis Clinical Site #2FairfaxVirginia22031-

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