ALX2004 for advanced or metastatic EGFR-expressing solid tumors
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
This trial will test ALX2004, an antibody-drug conjugate that targets EGFR, in people with advanced or metastatic non-small cell lung, head and neck, esophageal, or colorectal cancer to see if it is safe and shows tumor activity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ALX Oncology Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Tampa, Florida and 7 other locations) |
| Trial ID | NCT07085091 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase 1 trial administers ALX2004 to participants with advanced or metastatic NSCLC, HNSCC, ESCC, or colorectal cancer. The study starts with a dose-escalation (Phase 1a) portion to find a tolerable dose, followed by dose-exploration and a dose-expansion (Phase 1b) to further characterize safety and preliminary efficacy. Up to 170 previously treated patients will be enrolled across multiple US centers. Primary objectives focus on safety, tolerability, and dose selection with secondary endpoints including pharmacokinetics and tumor response.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed advanced or metastatic NSCLC, HNSCC, ESCC, or colorectal cancer who have progressed after prior therapies and have limited standard treatment options.
Not a fit: Patients who have effective approved standard therapies available, have disease amenable to curative surgery, or who have poor performance status or uncontrolled medical problems are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, ALX2004 could provide a new targeted treatment option that shrinks tumors or slows progression in patients with EGFR-targeted advanced solid tumors.
How similar studies have performed: Antibody-drug conjugates have produced notable successes in other tumor types, but EGFR-directed ADCs have shown mixed results and ALX2004 is being tested in humans for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent 1. 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. 2. 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 - 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 Exclusion Criteria: * Participants with disease suitable for local therapy with curative intent. * Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator * Prior treatment with any ADCs that have an active TOP1 inhibitor-based component
Where this trial is running
Tampa, Florida and 7 other locations
- ALX Center 7 — Tampa, Florida, United States (Recruiting)
- ALX Center 8 — Farmington Hills, Michigan, United States (Recruiting)
- ALX Center 3 — Grand Rapids, Michigan, United States (Recruiting)
- ALX Center 6 — Portland, Oregon, United States (Recruiting)
- ALX Center 5 — Houston, Texas, United States (Recruiting)
- ALX Center 4 — West Valley City, Utah, United States (Recruiting)
- ALX Center 2 — Fairfax, Virginia, United States (Recruiting)
- ALX Center 1 — Spokane, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Athanasios Tsiatis, MD
- Email: info@alxoncology.com
- Phone: 650-466-7125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.