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New treatment option for Advanced Colorectal Cancer
Official title Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06867822
What this study is testing
What is ProAgio?
ProAgio is an investigational medicine, being studied as a potential treatment for advanced colorectal cancer.
Also referred to as ACT50.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Be ≥18 years of age at the time of consent.
- Histologic or cytologic diagnosis of colorectal adenocarcinoma (CRC)
- Patients with advanced or metastatic CRC
- Performance status, ECOG: 0, 1
- For dose escalation phase: patients with CRC where FOLFIRI+ bevacizumab is considered appropriate standard therapy (previously treated with FOLFOX...
You likely can't join if
- Prior exposure to FOLFIRI chemotherapy
- Clinically significant peripheral neuropathy (\>=Grade 3 per CTCAE 5.0)
- Any untreated central nervous system (CNS) lesion. However, people are eligible if: a) all known CNS lesions have been treated with radiotherapy or...
- Allogenic bone marrow or solid organ transplant
- Known history or current interstitial lung disease or non-infectious pneumonitis
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of...
See the full eligibility criteria
Who can join
- Be ≥18 years of age at the time of consent.
- Histologic or cytologic diagnosis of colorectal adenocarcinoma (CRC)
- Patients with advanced or metastatic CRC
- Performance status, ECOG: 0, 1
- For dose escalation phase: patients with CRC where FOLFIRI+ bevacizumab is considered appropriate standard therapy (previously treated with FOLFOX based regimen in advanced/metastatic CRC is allowed). For dose expansion...
- Presence of a metastatic lesion that can be safely biopsied for correlative assays (Only for FOUR patients enrolling on the dose expansion phase).
- Patient must meet the following laboratory values at the screening visit:
- Absolute Neutrophil Count ≥1.5 x 109/L
- Platelets ≥100 x 109/L
- Hemoglobin (Hgb) ≥9 g/dL
- Creatinine Clearance ≥60 mL/min using Cockcroft-Gault formula
- Total bilirubin ≤1.5 x ULN
- Aspartate transaminase (AST) ≤2.5 x ULN, except for people with liver metastasis, who may only be included if AST ≤5.0 x ULN
- Alanine transaminase (ALT) ≤2.5 x ULN, except for people with liver metastasis, who may only be included if ALT ≤5.0 x ULN
- Urine dipstick reading for proteinuria \< 2+. Participants having ≥ 2+ proteinuria on urine dipstick testing at baseline will undergo a 24-hour urine collection for quantitative assessment of proteinuria and must...
- Blood pressure \<=160/100 mm Hg
- Presence of measurable disease by RECIST 1.1 criteria within 28 days prior to the first dose of study treatment.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0- 1 (Appendix A-Performance Status Criteria).
- Normal ECG defined as the following: QTcF at screening \<450 ms (male people), \<460 ms (female people)
- Before enrollment, a woman must be either:
- Not of childbearing potential: postmenopausal (\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \>40 IU/mL)...
- Of childbearing potential and practicing (during the study and for 6 months after receiving the last dose of study agent for women and 3 months after receiving the last dose of study agent for men)) a highly effective...
- Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above.
- A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at screening.
- During the study and for 6 months after receiving the last dose of study agent, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction.
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or...
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per HIPAA must be obtained from the subject or legally authorized representative (if...
- Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing and able to adhere to the prohibitions and...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
- Subject agrees not to participate in another treatment study while receiving study drug in present study
What rules you out
- Prior exposure to FOLFIRI chemotherapy
- Clinically significant peripheral neuropathy (\>=Grade 3 per CTCAE 5.0)
- Any untreated central nervous system (CNS) lesion. However, people are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease...
- Allogenic bone marrow or solid organ transplant
- Known history or current interstitial lung disease or non-infectious pneumonitis
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen, per treating physician discretion.
- Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to...
- Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: DPD testing is not mandatory as part of the trial and can be performed at the discretion of treating provider per local requirements)
- Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment
- Infection with human immunodeficiency virus (HIV)-1 or HIV-2. (Exception: Participants with well-controlled HIV [ie, CD4 \> 350/mm3 and undetectable viral load] are eligible.)
- Active hepatitis, including the following:
- Acute or chronic hepatitis B (Exception: Participants who are hepatitis B surface antigen [HbsAg] positive are eligible if they have hepatitis B virus (HBV) DNA less than 500 IU/mL or 2,500 copies/mL). Note...
- Infection with hepatitis C (Exceptions: [i] Participants who have no history of curative viral treatment and are documented to be viral load negative are eligible; [ii] Participants who have completed curative viral...
- Severe chronic or active infections requiring systemic parenteral antibacterial, antifungal or antiviral therapy; or any other potentially life-threatening viral or bacterial infection (participants on oral antibiotics...
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment or is currently enrolled in the treatment stage...
- A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 150 days after the last dose of study agent.
- Subject has had a major surgical procedure ≤ 28 days prior to randomization. Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper...
- Subject has psychiatric illness or social situations such as incarceration that would preclude study compliance, per investigator judgment
- Patients with a history of perforation, fistula, life-threatening gastrointestinal bleeding, proteinuria (\>1 gm/24 hours), wound healing issues
- Subject has significant cardiovascular disease, including any of the following:
- Congestive heart failure (defined as New York Heart Association [NYHA] Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular...
- History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes);
- History or family history of congenital long QT syndrome
- Cardiac arrhythmias requiring anti-arrhythmic medications (people with rate controlled atrial fibrillation for \> 1 month prior to randomization are eligible.)
- Deep venous thrombosis/pulmonary embolism (within last 6 months) unless adequately treated with therapeutic anticoagulation.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.