The transforming growth factor-β (TGF-β for short) is a protein that modulates the activity of immune cells. In cancer tissue it suppresses immune cell response and contributes to tumor growth and spread.
OT-101 is an investigational first-in-class RNA therapeutic designed to fight the immunosuppressive actions of TGF-β2, reduce the level of TGF-β2 in malignant tumors, and thereby delay the progression of disease.
OT-101 has demonstrated notable single-agent activity, consistently surpassing reported literature data for overall survival. Importantly, the overall survival increased in a dose-dependent manner at the levels of 140mg/m2 and higher.
The Phase 2/3 trial that you are being asked to participate in will compare OT-101 plus mFOLFORINOX with mFOLFORINOX alone as second line therapy in patients whose cancer progressed.
However, if you have any questions or need further assistance, please contact us.
stop-pc@cromospharma.comPlease contact us to discuss further.
stop-pc@cromospharma.comPrimary Objective
Secondary Objective
Primary Objective
Secondary Objective
Exploratory Objectives
Primary Endpoint
Secondary Endpoints
Safety Endpoints
Primary Endpoint
The primary endpoint is OS, defined as the time from date of Randomization to death due to any cause
Secondary Endpoint
Exploratory Endpoints
Safety Endpoints
The current study OT-01-P201 (STOP-PC) is a follow-on phase 2/3 trial building on five previous clinical trials conducted in Korea, the US, and the EU. These include two phase 2 trials involving over 200 patients:
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In these studies, OT-101 demonstrated clinical benefits in pancreatic ductal adenocarcinoma (PDAC), melanoma, and glioma, including documented cases of complete remission.
OT-101 works by adopting the patient’s immune system to target and eradicate tumors through the suppression of TGF-β2, a cytokine implicated in immune evasion and tumor progression.
Median survival for patients with low TGF-β2 expression was 72 months, compared to 15 months for those with high TGF-β2 levels.
When combined with irinotecan (a core component of the mFOLFIRINOX regimen), OT-101 extended median survival to over 34 months in patients with low TGF-β2 expression. Importantly, the modified FOLFIRINOX regimen (mFOLFIRINOX) used in STOP-PC has been shown to be safer while maintaining efficacy comparable to traditional FOLFIRINOX.
Recent developments further support OT-101’s potential:
2024 peer reviewed publications are available at Pubmed as follow:
The most common adverse events during the study were:
nausea (45.9%), fatigue (36.1%), abdominal pain (27.9%), and constipation (21.3%).
23.0% discontinued treatment due to adverse events.
The trial will have 2 parts:
Part 1 of the trial is designed to confirm the safety and tolerability of OT-101 at the 140 to 250 mg/m2/day dose level given on a 4-days-on, 10-days-off schedule in combination with mFOLFORINOX initiated on Day 1 of a 14-day cycle, for up to 12 cycles or until disease progression
For Part 2 patients in ARM 1 may continue on maintenance cycles with OT-101 (as shown below). After discontinuation of mFOLFIRINOX in the absence of tumor progression (ie, completion of the planned 12 cycles or unacceptable mFOLFIRINOX related toxicity), OT-101 will be administered IV on days 1-4 of a 14-day cycle as a single agent. Patients receiving OT-101 in Part 1 or 2 may be treated with OT-101 for more than 12 cycles.
For Arm 2 patients may receive mFOLFORINOX in both study arms for up to 12 cycles or 24 weeks or less in case the tumor progression.
Patients may receive mFOLFORINOX in both study arms for up to 12 cycles or 24 weeks and will be treated until tumor progression.