ProAgio for Colorectal Cancer

Overseen By Margaret Thomas, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Significant cardiovascular disease, CNS lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and potential benefits of a new drug, ProAgio, in combination with other cancer treatments for individuals with advanced or metastatic colorectal cancer. Participants will receive ProAgio alongside a standard chemotherapy mix (FOLFIRI) and another drug, bevacizumab, to evaluate the effectiveness of this combination and determine the safe dosage of the new drug. The trial seeks participants with advanced colorectal cancer who have not yet received the specific drugs being tested. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to understand any potential interactions or requirements.

Is there any evidence suggesting that ProAgio combined with FOLFIRI and bevacizumab is likely to be safe for humans?

Research shows that ProAgio, combined with FOLFIRI and bevacizumab, is under careful study for its safety in treating advanced colorectal cancer. Previous studies have focused on determining the right dose and assessing tolerance to this combination. While researchers continue to gather information on side effects, testing ProAgio in humans has indicated some initial safety.

In similar studies, ProAgio has been tested with other drugs to evaluate tolerance. Early results often aim to identify the safest dose, suggesting the treatment has shown some promise in terms of safety. However, as this is an early-phase trial, the primary goal is to better understand its safety.

The trial closely monitors any unwanted effects and adjusts doses to reduce risks. Researchers carefully observe participants to ensure their safety, addressing any side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

ProAgio is unique because it targets a novel mechanism in the treatment of colorectal cancer. Most treatments like FOLFIRI and bevacizumab focus on stopping cancer cell division or cutting off blood supply to tumors. However, ProAgio works differently by inducing apoptosis, or programmed cell death, specifically in cancer cells without affecting healthy cells. This precision could mean fewer side effects and a more effective therapy. Researchers are excited about ProAgio because it holds the potential to significantly improve outcomes for patients with advanced colorectal cancer.

What evidence suggests that ProAgio might be an effective treatment for colorectal cancer?

Research shows that ProAgio is a promising new treatment for colorectal cancer. This trial tests ProAgio in combination with standard chemotherapy drugs like FOLFIRI and bevacizumab. Early studies suggest that this combination may help control or shrink tumors in patients with advanced colorectal cancer. The trial includes a phase to determine the safe and effective dosage of ProAgio with FOLFIRI and bevacizumab, followed by an expansion phase to confirm the regimen's safety and provide preliminary data on its activity. Early results from these trials are crucial for understanding ProAgio's effectiveness against this type of cancer. However, more research is needed to confirm these encouraging early findings. ^{1 2 6 7 8}

Who Is on the Research Team?

Midun Malla, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic colorectal cancer (CRC) who haven't been treated before. They should be in good physical condition, with an ECOG performance status of 0-1, and have organs functioning well. People can't join if they've had recent surgeries, thromboembolic events, significant heart disease, or if they've previously received certain CRC treatments.

Inclusion Criteria

My colorectal cancer has spread to other parts of my body.

My white blood cell count is healthy.

My hemoglobin level is 9 g/dL or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase I dose-escalation to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab using an Accelerated titration BOIN design

4-6 months

Visits on Day 1, 8, 15, and 21 every 4-week cycle

Dose Expansion

Phase Ib dose-expansion to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab

4-6 months

Visits on Day 1 and 15 every 4-week cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• ProAgio

Trial Overview The trial tests ProAgio combined with FOLFIRI chemotherapy and Bevacizumab in patients with untreated advanced/metastatic CRC. It starts by finding the safest dose of ProAgio to use alongside standard therapy and then expands to more patients to confirm safety and effectiveness.

How Is the Trial Designed?

Group I: Phase Ib: dose expansion ProAgio + FOLFIRI + bevacizumab Experimental Treatment 3 Interventions

Once the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced/metastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.

Group II: Phase I: dose escalation ProAgio + FOLFIRI + bevacizumab dose levels tested for RP2D Experimental Treatment 3 Interventions

Dose level ProAgio mg/Kg FOLFIRI + bevacizumab 1. MTD-2 (6.4\*) FOLFIRI + bevacizumab 2. MTD-1 (10.7) FOLFIRI + bevacizumab 3. MTD (12.5) FOLFIRI + bevacizumab 4. MTD+1 (16\*) FOLFIRI + bevacizumab ProAgio will be administered via IV over 60 minutes on Day 1, 8, 15, and 21 every 4-week cycle. Bevacizumab 5 mg/kg, Irinotecan 180 mg/m2, 5-Flurouracil infusion 2400 mg/m2 will be administered via IV on Day 1, and 15 every 4-week cycle. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels listed above, maximum of 15 subjects.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

The V Foundation

Collaborator

Trials

10

Recruited

320+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06867822

Trial of ProAgio in Advanced/Metastatic Colorectal Cancer This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined ...

2. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-proagio-advanced-metastatic-colorectal-cancer-trial-nct06867822

Trial of ProAgio in Advanced/Metastatic Colorectal Cancer Benefits: Potential benefits of participating in this study include receiving a novel investigational treatment that may help control or shrink your cancer.

3. withpower.com withpower.com/trial/phase-2-advanced-colorectal-cancer-5-2025-0845e

ProAgio for Colorectal Cancer This Phase 1 medical study run by University of Alabama at Birmingham is evaluating whether ProAgio will have tolerable side effects & efficacy for patients ...

4. touchoncology.com touchoncology.com/insight/project-cure-crc-awards-nearly-5-million-to-accelerate-advancements-in-care/

Project Cure CRC Awards Nearly $5 Million to Accelerate ... Peritoneal metastasis in locally advanced colon cancer has a poor prognosis from 3 years post surgical resection. Dr Alvaro Arjona-Sanchez ( ...

5. colorectalcancer.org colorectalcancer.org/research/research-funded-project-cure-crc

Research Funded by Project Cure CRC The 2025 ASCO Annual Meeting featured several important studies that could change how colorectal cancer is treated, including a pivotal study for BRAF V600E ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06867822/

Trial | NCT06867822 This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined ...

7. cancer.gov cancer.gov/clinicaltrials/NCI-2025-02847

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC) - NCI This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined ...

8. policylab.us policylab.us/clinical-trials/l/conditions/metastatic-colorectal-cancer

Metastatic Colorectal Cancer Clinical Trials - Policy Lab The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.