Recruiting nowPhase 2
What this trial is trying to do
The platform is testing several drug regimens in people with advanced or high-risk solid tumours, including HER2-directed treatments and ALX148, which blocks a tumour “don’t eat me” signal used by cancer cells to evade immune cells. The researchers are asking whether these individual drugs or combinations can be given safely enough to move into larger trials.
The aim is to identify regimens suitable for further testing, rather than to compare one treatment directly with standard care. In this phase, improvement mainly means acceptable treatment-related side effects and enough evidence to justify a later trial; the study’s main outcome is adverse events, not longer survival or more time before the cancer grows.
Worth knowing: This is an open-label, non-randomised early-phase platform study with multiple tumour types and no comparison group, so it cannot establish that any regimen is better than existing treatment.
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 | NCT05868226 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 280 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | QuantumLeap Healthcare Collaborative |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug ALX148
- Drug Fam-Trastuzumab Deruxtecan-Nxki
- Drug Zanidatamab
- Drug Tucatinib
- Drug TTX-MC138
What it is measuring
Incidence of Adverse Events related to the treatment
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 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial in a timely manner.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Rectal
- Colon
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
General Inclusion Criteria (GIC):
- GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks for research. If FFPE blocks cannot be submitted, 20 to 40 freshly cut FFPE tissue slices (4 to 7 microns thick each) from a representative FFPE block, mounted on charged glass slides and left unstained will be acceptable. This criteria can be modified in specific drug regimens.
- GIC2: Age ≥ 18 years at the time of signing the informed consent
- GIC3: Gender: Male or female (premenopausal and postmenopausal)
- GIC4: ECOG performance status Grade 0-2.
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 10 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?
The source
Registry record NCT05868226, registered by QuantumLeap Healthcare Collaborative 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.