ALX2004 for advanced or metastatic EGFR-expressing solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ALX Center 9
  La Jolla, California, United States Recruiting
• ALX Center 11
  Santa Monica, California, United States Recruiting
• 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 12
  Morristown, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Athanasios Tsiatis, MD
• Email: info@alxoncology.com
• Phone: 650-466-7125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.