BridgeMD
New treatment option for NSCLC (Advanced Non-small Cell Lung Cancer)
Official title A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
ClinicalTrials.gov ID: NCT07085091
What this study is testing
What is ALX2004?
ALX2004 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc (advanced non-small cell lung cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease...
- Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced/metastatic setting and for whom no...
- Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors...
- Adequate Bone Marrow Function
- Adequate Renal \& Liver Function
You likely can't join if
- 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...
- Prior treatment with any ADCs that have an active TOP1 inhibitor-based component
See the full eligibility 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
- 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...
- Adequate Bone Marrow Function
- Adequate Renal \& Liver Function
- Adequate Performance Status
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Farmington Hills, Michigan, United States
- Grand Rapids, Michigan, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Farmington Hills, Michigan, United States; Grand Rapids, Michigan, United States; Portland, Oregon, United States; Houston, Texas, United States; West Valley City, Utah, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.