No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
ALX Oncology Inc. · Industry
Who this trial is looking for
This trial is looking for people with advanced or metastatic solid tumors like lung or colorectal cancer. Participants will receive a new treatment called ALX2004 to see how it affects their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced or metastatic head and neck cancer.
I have been diagnosed with advanced non-small cell lung cancer.
I have been diagnosed with advanced esophageal squamous cell carcinoma.
I have been diagnosed with advanced colorectal cancer.
I have had no more than 3 prior lines of therapy for my cancer.
I have adequate bone marrow function.
I have adequate kidney and liver function.
I have an acceptable performance status.
You may not be able to join if
I have a type of cancer that can be treated with local therapy to cure it.
I have a life expectancy of less than 3 months.
My cancer is progressing rapidly.
I have received treatment with certain antibody drug conjugates that include a topoisomerase 1 inhibitor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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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 follow…
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
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