A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
ALX Oncology Inc.
Study ID
NCT07085091
Phase
PHASE1
Status
Recruiting
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Conditions

  • CRC (Colorectal Cancer)
  • Colo-rectal Cancer
  • ESCC
  • Esophageal Squamous Cell Carcinoma (ESCC)
  • HNSCC
  • Head and Neck Cancer
  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

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

Interventions

  • ALX2004 — DRUG
    ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
  • ALX2004 — DRUG
    ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
  • ALX2004 — DRUG
    ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion

Study Details

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

Key Dates

Start date
Aug 18, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ALX2004 Phase 1a (Dose Escalation)
    ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase
  • Experimental: ALX2004 Phase 1a (Dose Exploration)
    ALX2004 will be administered. All or a subset of tumors tested in dose escalation will enroll into 1 or 2 dose levels during the dose exploration phase
  • Experimental: ALX2004 Phase 1b (Dose Expansion)
    ALX2004 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase

Primary Outcome Measure

Phase 1a: Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
ALX Center 7TampaFlorida33612-
ALX Center 8Farmington HillsMichigan48334-
ALX Center 3Grand RapidsMichigan49546-
ALX Center 6PortlandOregon97213-
ALX Center 5HoustonTexas77030-
ALX Center 4West Valley CityUtah84119-
ALX Center 2FairfaxVirginia22031-
ALX Center 1SpokaneWashington99208-

Find similar trials in Tampa, FL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
ALX Center 7· Tampa, FLALX Center 8· Farmington Hills, MIALX Center 3· Grand Rapids, MIALX Center 6· Portland, ORALX Center 5· Houston, TXALX Center 4· West Valley City, UT

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