Recruiting nowPhase 1
| Registry number | NCT04999761 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 917 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Taiho Pharmaceutical Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug AB122
- Drug TAS-116
- Drug TAS-120
- Drug TAS-115
- Drug TAS-102
- Drug Ramucirumab
- Drug Bevacizumab
- Drug Fluorouracil
- Drug Cisplatin
- Drug AB154
- Drug Carboplatin
- Drug nab-Paclitaxel
What it is measuring
Phase 1a (All cohorts except Cohort D-4, D-5 and D-9) : Percentage of participants who experience a Dose Limiting Toxicity (DLT)
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
This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS wild-type
- Metastatic
- 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
- Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;
- Has adequate organ function as defined by the following criteria:
- AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN
- T-Bil of ≤ 1.5 × ULN
- ANC ≥ 1500 /mm3 (ie, ≥ 1.5 × 109 /L by International System of Units [SI]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF])
- Platelet count ≥ 100000 /mm3 (SI: ≥ 100 × 109 /L) (excluding measurements obtained within 7 days after a transfusion of platelets)
- Hemoglobin value of ≥ 9.0 g/dL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood
- Has a life expectancy of at least 90 days;
Cohort A-1 and A-2
- Japanese male and female;
- Has a histologically or cytologically confirmed diagnosis of solid tumor;
- Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;
Cohort B-1
- Has a histologically or cytologically confirmed diagnosis of PDAC;
- Has disease pro…
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 9 sites. Listed in: Japan.
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 NCT04999761, registered by Taiho Pharmaceutical Co., Ltd. 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.