Trial Lifecycle
Marks the official start of site participation in the clinical trial process
Site Initiation Visit
Ponsegromab binds this circulating cytokine, preventing its interaction with this hindbrain receptor.
GDF‑15 and GFRAL
Tisotumab vedotin targets this cell‑surface protein highly expressed in >95% of recurrent/metastatic cervical cancers.
What is tissue factor (TF)?
Tucatinib is used to treat metastatic colorectal cancer driven by overexpression of this receptor.
What is HER2?
This gene mutation defines the primary population treated with encorafenib‑based regimens in BREAKWATER.
What is BRAF V600E‑mutant mCRC?
Verifies feasibility and readiness before enrolling participants in the trial
Pre-Trial Assessment
RIVER‑mPDAC (C3651021) evaluates ponsegromab plus background chemotherapy in this line of therapy for this tumor context.
First‑line metastatic PDAC with cancer cachexia.
Name two AE categories of special interest for TV besides ocular toxicity
Any two of: peripheral neuropathy, hemorrhage, pneumonitis, severe cutaneous adverse reactions, embryo‑fetal toxicity
The combination studied in MOUNTAINEER pairs tucatinib with this targeted biologic.
What is trastuzumab?
In BREAKWATER, encorafenib is paired with this EGFR inhibitor.
What is cetuximab?
Occurs in early-phase studies to determine safe and effective drug dosage levels.
Dose Escalation
In Phase 2 POC study C3651003, eligibility included elevated GDF‑15—state the approximate threshold used.
≥1500 pg/mL
Under normal physiology, TF plays this key role
Initiates the coagulation cascade after vascular injury
The sponsor‑expanded MOUNTAINEER trial enrolled patients who were RAS wild‑type and positive for HER2 by IHC, FISH, or this test type.
What is next‑generation sequencing (NGS)?
The phase 3 BREAKWATER regimen combines encorafenib + cetuximab with this chemotherapy backbone in its primary arm.
What is mFOLFOX6?
Ensures unbiased treatment assignment
Randomization
In the NEJM Phase 2 study, most participants fell into three tumor groups. Name two of the three.
Any two of: NSCLC, pancreatic cancer, colorectal cancer.
The boxed warning in the US Prescribing Information for tisotumab vedotin highlights toxicity to this organ system.
What is ocular toxicity?
The most common tucatinib‑related adverse event in HER2+ mCRC, occurring in over half of patients
What is diarrhea?
Cohort 3 of BREAKWATER evaluates encorafenib + cetuximab with this alternative chemotherapy backbone.
What is FOLFIRI?
a standardized set of rules used in cancer clinical trials to objectively measure how tumors in solid cancers respond to treatment, classifying outcomes as Complete Response, Partial Response, Stable Disease, or Progressive Disease, by tracking tumor size changes on imaging like CT scans to determine treatment effectiveness.
RECIST (Response Evaluation Criteria in Solid Tumors)
In the NEJM Phase 2 study, patients received one of three dose levels of ponsegromab or placebo. State the highest dose evaluated.
What is 400 mg?
Tisotumab vedotin delivers this cytotoxic payload once internalized into tumor cells.
What is MMAE (monomethyl auristatin E)?
In Cohort C of MOUNTAINEER, patients could cross over to dual therapy if they had not achieved a PR or CR by this week.
What is week 12?
BREAKWATER’s first‑line encorafenib regimen received accelerated approval under this FDA initiative designed for early‑line settings.
What is Project FrontRunner?