Solid Tumor, Adult study: CT3001 vs FOLFOX
Official title A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06598007
What this study is testing
What is CT3001?
CT3001 is an investigational oral solution being studied as a potential treatment for advanced solid tumors.
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
- The study wants to see how safe CT3001 is and find the best dose. It also looks at whether CT3001 works with standard chemotherapy for colorectal cancer.
- Who it's for
- Adults with advanced solid tumors who have no other treatment options, and those with colorectal cancer who can receive FOLFOX chemotherapy.
- What's involved
- Participants will receive CT3001 at different doses. In phase 2, they will also get the usual FOLFOX chemotherapy. They will have regular visits and medical tests to monitor safety and any signs of the drug working.
- Time commitment
- The study lasts several months, with multiple clinic visits for dosing, blood tests, imaging, and safety checks. The exact number of visits depends on the dose level and phase of the study.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
- Aged ≥ 18 years (or adult age as per local regulations).
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom...
- Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has...
- Life expectancy ≥ 3 months, in the opinion of the PI or designee.
You likely can't join if
- During Phase 1 Dose Escalation, receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy [excluding the...
- Use of other IP within 5 half-lives of the product (if the IP is a small molecule) or anti-cancer investigational medical device within two weeks...
- Evidence of severe or uncontrolled systemic diseases, infection, or laboratory finding that in the view of the PI or designee makes it undesirable...
- Females who are pregnant or nursing, or any participant who is planning to become pregnant (self or partner) at any time during the study, including...
- Has had major surgery or significant traumatic injury within 4 weeks of start of CT3001
- Has a prolonged QT interval corrected by Fredericia's formula (QTcF interval) of \> 470 ms (determined by average of 3 readings on triplicate 12-lead...
See the full eligibility criteria
Who can join
- Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
- Aged ≥ 18 years (or adult age as per local regulations).
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists.
- Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.
- Life expectancy ≥ 3 months, in the opinion of the PI or designee.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Absolute neutrophil count ≥ 1.5 × 10\^9/L without growth factor support in the 2 weeks prior to study entry.
- Hemoglobin ≥9.0 g/dL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry.
- Serum TBIL \< 1.5 × ULN.
- AST and ALT \ 60 mL/min, as per the Cockcroft-Gault Equation: CGGFR = [(140 - age in years) × weight in kg] / (7.2 × serum creatinine in mg/dL) (× 0.85 for females) (for urine protein \ 2+, 24-hour urinary protein...
- Coagulation tests: international normalized ratio (INR) \< 1.5, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Note: for those on oral anticoagulants, an INR in the range of 2 to 3 is acceptable).
- Participants (both males and females) of childbearing potential should be willing to use a viable contraception method that is deemed effective by the PI or designee from Screening, during the study, and for at least 3...
What rules you out
- During Phase 1 Dose Escalation, receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy [excluding the following small-area radiotherapy for bone metastasis], endocrine therapy...
- Use of other IP within 5 half-lives of the product (if the IP is a small molecule) or anti-cancer investigational medical device within two weeks prior to the first administration of CT3001.
- Evidence of severe or uncontrolled systemic diseases, infection, or laboratory finding that in the view of the PI or designee makes it undesirable for the patient to participate in the trial.
- Females who are pregnant or nursing, or any participant who is planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.
- Has had major surgery or significant traumatic injury within 4 weeks of start of CT3001; participants have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or...
- Has a prolonged QT interval corrected by Fredericia's formula (QTcF interval) of \> 470 ms (determined by average of 3 readings on triplicate 12-lead ECG) or has a history of additional risk factors for Torsade de...
- Any psychiatric, psychological, familial or geographical condition that, in the judgment of the PI or designee, may interfere with the treatment and follow-up, affect compliance or place the participant at high risk of...
- Blood donation or significant blood loss within 60 days prior to the first administration of CT3001.
- History of severe allergic or anaphylactic reactions, or sensitivity to the CT3001 or its constituents.
- Vaccination with a live vaccine within 4 weeks prior to the first administration of CT3001.
- Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 5 half-lives of the product prior to the first administration of CT3001
- Use of any medications with a narrow therapeutics index that are sensitive substrates of and metabolized mainly through CYP2C8 within 5-half-lives of the products prior to the first administration of CT3001
- Use of any gastric acid reducing agents during the time period between 6 hours prior to and 2 hours after the administration of CT3001.
- Has chronic hepatitis B virus (HBV) infection or virologically suppressed (VS) HBV AND has been on suppressive antiviral therapy (unless it is a prohibited medication per exclusion criteria #12) for at least 4 weeks.
- Has chronic HCV infection but has completed curative antiviral treatment (note: patients may be HCV antibody positive but must be HCV RNA negative to be eligible).
- Anything that the PI considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, 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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.