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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ALX2004 in people with certain solid cancers that have grown nearby, come back, or spread. ALX2004 links an antibody to a cancer drug and targets EGFR, a protein. This is the first study of ALX2004 in humans.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cancer confirmed by a tissue test: head and neck squamous cell cancer, non-small cell lung cancer, esophageal squamous cell cancer, or colorectal cancer. The cancer must have grown nearby, come back, or spread. Nearby or returning cancer must not be curable with surgery.
  • For the dose-escalation part, which tests increasing doses: cancer must have returned or worsened after treatment for advanced or spread cancer, with no approved or standard treatment available.
  • For the dose-exploration and dose-expansion parts: people with head and neck or esophageal cancer must have had no more than 3 courses of different treatments for advanced or spread cancer.
  • For those same parts, people with lung cancer must have had no more than 2 courses of different chemotherapy treatments for advanced or spread cancer. Those with a treatable tumor change must have received the standard targeted treatment. Those without one must have received platinum chemotherapy and checkpoint inhibitor treatment, which helps the immune system fight cancer.
  • For those same parts, people with colorectal cancer and a treatable tumor change must have received standard treatment for that change. They must have had at least 2 courses of different chemotherapy treatments and no more than 4 courses of different treatments for advanced or spread cancer.
  • For those same parts, people with colorectal cancer without a treatable tumor change must have had at least 2 courses of different chemotherapy treatments, including oxaliplatin, and VEGF treatment, which targets blood vessel growth. They must have had no more than 4 courses of different treatments for advanced or spread cancer.
  • Have bone marrow, kidneys, and liver that work well enough.
  • Be well enough to carry out daily activities, as required by the study.

Who can't join

  • Cancer could be cured with treatment aimed only at the cancer site.
  • The study doctor expects you to live less than 3 months, or your cancer is worsening quickly, such as causing bleeding or pain that is not controlled.
  • Past treatment with an antibody-linked cancer drug containing a TOP1 inhibitor, a drug that blocks an enzyme cancer cells use to grow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (12)

CA

FL

MI

NJ

OH

OR

TX

UT

VA

WA