Recruiting nowPhase 1Randomised
| Registry number | NCT07543744 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | randomised, blinded |
| Taking part | 180 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | R-Pharm |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug RPH-030
- Drug Vectibix®
- Drug Irinotecan
- Drug Calcium Folinate
- Drug Fluorouracil
What it is measuring
Area under the pharmacokinetic curve "concentration-time" (AUC(0-336)) of panitumumab
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.
What this trial is trying to do
RPH-030 is being tested as a possible biosimilar to Vectibix (panitumumab), an antibody that blocks the EGFR growth signal, alongside FOLFIRI chemotherapy. The researchers are testing whether the two treatments have equivalent drug levels in the blood and comparable safety and immune reactions after the first infusion.
The idea is that RPH-030 could provide the same treatment exposure and safety profile as Vectibix while being used with standard first-line FOLFIRI for metastatic colorectal cancer. The main measure is drug exposure, not whether patients live longer or go longer before the cancer grows; tumour response is only a pilot assessment.
Worth knowing: This is a phase 1 equivalence study, so its main purpose is pharmacokinetics and safety rather than proving that either treatment improves cancer outcomes.
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.
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
The primary objective of this study is to demonstrate equivalence of pharmacokinetic properties, and comparability of safety and immunogenicity parameters of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI. The additional objective is to perform a pilot evaluation of the efficacy of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS wild-type
- 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
1. A voluntarily signed and dated Informed Consent form (ICF) of the patient
2. Histologically verified (documented results of respective examinations available) metastatic colorectal adenocarcinoma (in case the results of previous examinations are not available, the diagnosis will be verified in the central laboratory during screening upon receipt and evaluation of the results before randomization)
3. Patient consent to undergo a screening biopsy if archival tissue samples are unavailable for histological diagnosis verification
4. Patients with metastatic colorectal cancer (mCRC), either de novo metastatic or recurrent with distant metastases, who are candidates for first-line therapy
5. RAS wild-type (WT) status
6. ECOG status 0-1
7. Presence of at least one measurable lesion according to RECIST 1.1 criteria (patients with a single measurable bone lesion are not eligible)
8. Absence or resolution of toxic effects from prior therapy (neoadjuvant/adjuvant) or surgical complications to ≤ Grade 1 according to CTCAE v5.0, except for chronic/irreversible adverse events that do not impact the safety profile of the study treatment (e.g., alopecia)
9. Serum magnesium ≥ 0.66 mmol/L, total calcium ≥ 2.15 mmol/L, and potassium ≥ 3.5 mmol/L at the time of randomization
10.
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 26 sites. Listed in: Russia.
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 NCT07543744, registered by R-Pharm 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.