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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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC (left sided); locally advanced or recurrent disease must not be amenable to resection with curative intent

‣ Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced/metastatic setting and for whom no approved or standard therapy is available.

⁃ Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.

∙ HNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting

∙ NSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting. For participants without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting

∙ ESCC - Received no more than 3 prior lines of therapy in the advanced/metastatic setting

∙ CRC (left-sided) - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting. For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting.

• Adequate Bone Marrow Function

• Adequate Renal \& Liver Function

• Adequate Performance Status

Locations
United States
Florida
ALX Center 7
RECRUITING
Tampa
Michigan
ALX Center 3
RECRUITING
Grand Rapids
Oregon
ALX Center 6
RECRUITING
Portland
Texas
ALX Center 5
RECRUITING
Houston
Utah
ALX Center 4
RECRUITING
West Valley City
Virginia
ALX Center 2
RECRUITING
Fairfax
Washington
ALX Center 1
RECRUITING
Spokane
Contact Information
Primary
Athanasios Tsiatis, MD
info@alxoncology.com
650-466-7125
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 170
Treatments
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
Sponsors
Leads: ALX Oncology Inc.

This content was sourced from clinicaltrials.gov