A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

NCT06079346 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OT-01-P201
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  To compare the efficacy of OT-101 in combination with mFOLFIRINOX versus mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer as measured by overall survival (OS)

  2.5 years

Secondary Outcomes (5)

• Pharmacokinetic (PK) Parameter - Area Under the Curve (AUC)

  1 year

• Pharmacokinetic (PK) Parameter - Cmax

  1 year

• Progression-Free Survival (PFS)

  2.5 years

• Objective Response Rate (ORR)

  2.5 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  2.5 years

Study Arms (2)

OT-101 + mFOLFIRINOX

ACTIVE COMPARATOR

OT-101 IV dosed on Days 4-7 plus mFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle

Drug: OT-101; Drug: mFOLFIRINOX

mFOLFIRINOX Only

PLACEBO COMPARATOR

mFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle

Drug: mFOLFIRINOX

Interventions

OT-101 DRUG

OT-101: antisense oligodeoxynucleotide complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene

OT-101 + mFOLFIRINOX

mFOLFIRINOX DRUG

Folinic acid, 5-FU, Irinotecan, Oxaliplatin

OT-101 + mFOLFIRINOX; mFOLFIRINOX Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of advanced and unresectable or metastatic pancreatic adenocarcinoma confirmed by:
• Histopathology from primary tumor in pancreas, OR
• Histopathology from a non-pancreatic lesion in the presence of a mass in the pancreas consistent with pancreatic adenocarcinoma or a medically documented history of pancreatic adenocarcinoma.
• Measurable disease per RECIST v.1.1
• Male or non-pregnant, non-lactating female, ≥18 years or age
• If a female patient is of child-bearing potential, as evidenced by menstrual periods, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin \[β- hCG\]) documented prior to the first administration of stud drugs
• Female patients of childbearing age and women \< 12 months since the onset of menopause must agree to use acceptable contraceptive methods for the duration of the study and 9 months following the last injection of OT-101.
• Male patients must use effective contraception for a duration of 6 months after the final dose, as per the prescribing information for oxaliplatin.
• Provide signed written informed consent
• Eastern Cooperative Group (ECOG) Performance Status (PS) score of 0-1
• Willingness and ability to comply with study requirements
• Patient has adequate organ function by the following laboratory assessments at baseline(obtained ≤28 days prior to Randomization):
• Hematologic
• Platelets ≥100×109/L
• Hemoglobin ≥9.0 g/dL

You may not qualify if:

• Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (ie,lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
• Patient has experienced a decrease in ECOG PS between Screening visit and within 72 hours prior to Randomization
• Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with t½ of less than 24 hours
• History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (eg, breast and prostate) for which the patient has been disease-free for at least 3 years. Patients with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study
• Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for the study
• Patients with abnormal electrocardiogram (ECG) at baseline (QT or QTc interval \>470 ms) will be excluded from this study. The eligibility of patients with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the Sponsor's medical representative in consultation with the principal investigator.
• Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
• Known history of positivity (regardless of immune status) for human immunodeficiency virus(HIV)
• Known history of chronic active or active viral hepatitis A, B, or C infection
• Clinically significant bleeding within 2 weeks prior to Randomization (eg, gastrointestinal\[GI\] bleeding or intracranial hemorrhage)
• Pregnant or lactating women
• Myocardial infarction, coronary bypass surgery, or arterial thromboembolic events within the last 6 months prior to Randomization, symptomatic congestive heart failure (New York Heart Association Classification \>Class II, unstable angina, or unstable cardiac arrhythmia requiring medication
• Clinically significant ascites defined as requiring ≥1 paracentesis every 2 weeks
• Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to Randomization or anticipated surgery during the study period
• Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1, anti-PD-L1)

Sponsors & Collaborators

• Oncotelic Inc.: lead

Study Sites (2)

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Central Study Contacts

Cynthia Lee, PhD

CONTACT

(650) 635-7024; clee@oncotelic.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 12, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)