Recruiting nowPhase 1
What this trial is trying to do
ASP1002 is designed to attach to CLDN4, a protein found on some tumour cells, and activate the immune system against them. This first-in-human study tests ASP1002 alone and alongside standard chemotherapy or immunotherapy, while researchers determine a tolerable dose and examine whether it changes tumour growth or immune markers.
The researchers hope that directing an immune attack towards CLDN4 could control advanced cancers, including colorectal cancer, but this trial is mainly measuring dose-limiting toxicities and other safety information rather than whether people live longer or remain cancer-free. It also measures how the body processes ASP1002 and looks for early signs of tumour slowing.
Worth knowing: This is a non-randomised Phase 1 study with no comparison group, so its main purpose is safety and dose-finding, not proving benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05719558 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 798 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Astellas Pharma Global Development, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug ASP1002
- Drug Bevacizumab
- Drug Oxaliplatin
- Drug Leucovorin
- Drug Fluorouracil
- Drug Irinotecan
- Drug Trifluridine-Tipiracil
- Drug Pembrolizumab
- Drug Pemetrexed
- Drug Carboplatin
- Drug Ramucirumab
- Drug Docetaxel
What it is measuring
Incidence of Dose Limiting Toxicities (DLTs) for ASP1002
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
ASP1002 is being studied in people with tumors that have spread to nearby tissue (locally advanced) that cannot be removed by surgery (unresectable) or tumors that have spread to other parts of the body (metastatic). Claudin 4 protein, or CLDN4, is a protein found on tumors in different parts of the body. ASP1002 is thought to work by attaching to the CLDN4 protein in the tumor. This switches on the body's immune system to attack the tumor.
Before ASP1002 can be used, researchers need to collect information about the safety of ASP1002 and how people with tumors tolerate it. In this study, ASP1002 will be given to humans for the first time. It will either be given by itself or together with other cancer treatments. These include standard chemotherapies (mFOLFOX6, FOLFIRI, TAS-102, pemetrexed, carboplatin, and docetaxel) and immunotherapies (bevacizumab, pembrolizumab, and ramucirumab). Immunotherapy is a treatment that works with the body's immune system to treat tumors.
This is an early development study. These studies are mostly about safety, but also to find the most suitable dose.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- BRAF V600E
- Metastatic
- Locally advanced
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
For Monotherapy
- Participant has locally-advanced (unresectable or metastatic solid tumor) confirmed by available pathology records or current biopsy.
a. For monotherapy dose escalation, participant must have one of the following malignancies:NSCLC-adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded, UC, CRC, prostate adenocarcinoma, epithelial ovarian cancer (including fallopian tube cancer) and triple-negative breast cancer (TNBC).
- TNBC defined as unequivocal TNBC histology (ER 1 negative/progesterone receptor-negative/HER2-negative). This is defined by < 1% expression of ER and progesterone receptor by IHC and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and FISH negative (not amplified) as per current ASCO/CAP guidelines [Hammond et al, 2010].
b.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 15 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT05719558, registered by Astellas Pharma Global Development, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.