PT0511 for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to assess the safety and tolerability of PT0511, a new potential drug, for individuals with solid tumors, including colorectal cancer. The study will also identify the optimal dosage for further testing. Participants will receive PT0511 either alone or with cetuximab, depending on their tumor type. The trial seeks adults with advanced or metastatic solid tumors who have specific KRAS gene changes and have undergone up to four prior treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use strong or moderate CYP3A4/5 or P-gp inhibitors or inducers. If you're on these, you may need to stop or adjust them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PT0511 is currently being tested for safety and tolerability. Since the study is in its early stages, detailed information about reactions to PT0511 is limited.
Cetuximab, however, is an approved medication for treating certain cancers, such as colorectal cancer. Most people tolerate it well, but it can cause side effects like skin rash and low magnesium levels in the blood. About 55% of patients may experience low magnesium, which requires management during treatment.
Prospective trial participants should discuss the potential risks and benefits with their healthcare provider. This conversation can help clarify the known side effects of cetuximab and the uncertainties surrounding PT0511.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PT0511 for colorectal cancer because it offers a fresh approach by directly targeting specific tumor types. Unlike standard treatments like chemotherapy, which can affect both cancerous and healthy cells, PT0511 is designed to selectively act on cancer cells based on their specific characteristics. This targeted action has the potential to reduce side effects and increase effectiveness. Furthermore, its use in combination with cetuximab for certain tumor types suggests a strategic enhancement of existing therapies, potentially improving outcomes for patients who have limited options.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that PT0511 is under investigation for its potential to treat solid tumors, such as colorectal cancer. This trial includes various treatment arms where participants receive PT0511 alone or with cetuximab, a known cancer treatment. PT0511 targets specific processes that help tumors grow, potentially slowing or stopping cancer progression. Although detailed results in humans remain limited, combining PT0511 with cetuximab is a strategic approach to enhance effectiveness. Early studies aim to determine the optimal dose that maximizes benefits while managing side effects. The goal is to significantly impact cancer cells while ensuring patient safety.678910
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that have a KRAS mutation or amplification. They must have tried at least one, but no more than four, systemic therapies or be unable to tolerate them. Participants should be in good physical condition (ECOG 0-1) and not planning to conceive.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants with solid tumors receive PT0511 infusion until disease progression or intolerance to determine the maximally tolerated dose
Dose Expansion
Participants receive PT0511 infusion, with or without cetuximab, until disease progression or intolerance to evaluate safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cetuximab
- PT0511
Trial Overview
The study tests the safety and tolerability of PT0511 alone and combined with cetuximab to find the highest dose patients can take without severe side effects. It's focused on those with colorectal cancer for the combination therapy part.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants with tumor type 8 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Participants with tumor type 7 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Participants with tumor type 6 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Participants with tumor type 5 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Participants with tumor type 4 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Participants with tumor type 3 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Participants with tumor type 2 will receive PT0511 infusion in combination with cetuximab infusion, until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Participants with tumor type 1 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0511 established in Part 1a.
Participants with solid tumors with any KRAS mutation or amplified WT KRAS will receive PT0511 infusion, intravenously (IV), until disease progression or intolerance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PAQ Therapeutics, Inc.
Lead Sponsor
Citations
PT0511 for Colorectal Cancer
The study tests the safety and tolerability of PT0511 alone and combined with cetuximab to find the highest dose patients can take without severe side effects.
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