ROSETTA CRC 203 Eligibility criteria
Participants must have this type of colorectal cancer, confirmed by histology, that is not amenable to curative surgery.
Recurrent or metastatic colorectal adenocarcinoma
This QTc interval threshold (in milliseconds) excludes participants with congenital long QT syndrome or QTc prolongation above this value from the study.
480 msec
If FFPE blocks cannot be provided, a minimum of this many unstained slides must be submitted, and they must be freshly cut within 4 months.
15 unstained slides
Hematology, chemistry, and urinalysis laboratory assessments are expected to be performed locally within these many hours prior to each dose.
72 hours
Sites must request these items themselves, so checking inventory early helps prevent delays.
Central lab study kits
For Phase 2, these two locally tested RAS gene mutation statuses must be documented prior to randomization.
KRAS and NRAS
Palliative radiotherapy must be completed for this length of time prior to randomization.
At least 14 days prior to randomization
If a fresh tumor biopsy poses significant risk to the participant, this type of tissue sample may be submitted instead if the patient has not received any anti-cancer therapy since sampling.
Archived tumor tissue
A surveillance brain MRI is expected to be performed this often while on-treatment and in follow-up if the participant has a known history of brain metastasis.
Every 12 weeks
This certificate should be completed for at least one site personnel and submitted to the imaging vendor prior to screening first study participant?
Clario Training Certificate
To be eligible, participants with previously treated CNS metastases must be neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least this many weeks prior to randomization.
2 weeks
To be eligible for the study, participants must have an ECOG performance status score of one of these two values.
0 or 1
These samples are collected at these different timepoints on the same visit day?
Pre-dose and End of Infusion PK samples
Pregnancy testing for individuals of child-bearing potential is performed this often for participants on a Q2W schedule.
Every 4 weeks OR every other cycle
This vendor will be used to manage PRO assessments in phase 3 portion of the study?
Clario
A prior malignancy active within this timeframe of enrollment, except for certain low-risk cancers, will exclude a participant from the study.
2 years
This length of time before randomization is the exclusion window if a participant has had major surgery, an open biopsy, or a significant traumatic injury—or is expected to need major surgery during the study intervention.
Within 28 days prior to randomization
In this study, only these two blood sample types are sent in ambient condition on the day of collection.
Immunophenotyping and ctDNA samples
Even if dosing is delayed, these assessments should continue as per protocol.
Tumor assessments
These transactions within Endpoint (IRT system) can only be performed by Unblinded site pharmacists or drug preparer
Study treatment visit transactions
Known deficiency in this enzyme, which must be systematically screened for where locally mandated, is an exclusion criterion.
DPD (dihydropyrimidine dehydrogenase)
These sponsor pre‑approved local tumor tissue assay results must be submitted before a participant can be randomized.
PD‑L1 results obtained using sponsor‑pre‑approved local PD‑L1 IHC assays or sponsor‑provided central laboratory testing that are available in IRT during the screening period prior to randomization
This scan schedule applies during treatment until Week 54 starting C1D1
Imaging frequency of every 6 weeks (±7 days)
These are the two timepoints for safety follow up visits after the last dose?
Day 30 and Day 90
Participants can use this app to track payments related travel, meal reimbursements and stipends
Mural Health