A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors
A Phase 1/2 First-In-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CT3001 in Patients With Advanced Solid Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants may be hospitalized from C0D1 through to C0D4, if required by the sites, to perform frequent blood draws for PK and safety assessments."
- "Again, participants may be hospitalized from C1D1 through to C1D8, if required by the sites, to perform frequent blood draws for PK and safety assessments. * From Cycle 2 onwards, participants will receive CT3001 (orally QD or BID) in repeated 21-day cycles (i.e., Cycle 2, Cycle 3, Cycle 4, Cycle 5, etc.)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests CT3001 in adults with advanced solid tumors who have no suitable standard treatment. It looks at safety and the best dose. A later part tests CT3001 with FOLFOX chemotherapy for advanced colon or rectal cancer in people who can restart FOLFOX, to see how safe it is and whether it may help.
This is an FIH, multicenter, open-label, dose escalation and dose expansion/dose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 7 dose levels of CT3001. Phase 2b is a dose finding/dose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18, or the legal adult age where you live. Understand the study, agree to join, and be willing to finish its tests.
- Have a confirmed solid tumor that has spread or cannot be removed by surgery. Standard treatment must have stopped working or not be available.
- For Phase 2b, have advanced colon or rectal cancer and be able to restart FOLFOX chemotherapy.
- Have cancer that can be measured on scans. If the area was treated before, scans must show that the cancer has grown since then.
- Be expected to live at least 3 months.
- Be fully active, or able to walk and do light work despite limits on harder activity.
- Meet the study's blood count, liver, kidney, urine protein, and blood-clotting test limits.
- If able to have children, use approved birth control from screening until at least 3 months after the last dose. Men must not donate sperm until 3 months after the last dose.
Who can't join
- Get other cancer treatment during Phase 1, except certain small-area radiation treatments for cancer in bones. FOLFOX is allowed in Phase 2b. Recent or ongoing use of other study drugs or devices may also rule you out.
- Have a severe or poorly controlled illness, infection, or test result, or any condition or life situation that could make treatment unsafe or prevent study visits.
- Be pregnant or breastfeeding, or plan for yourself or your partner to become pregnant during the study or follow-up.
- Have major surgery or a serious injury within 4 weeks before treatment, have not recovered from major surgery, or may need major surgery during the study. Blood donation or major blood loss within 60 days also rules you out.
- Have certain abnormal heart rhythms, risk factors for a dangerous heart rhythm, or take medicines that can cause these rhythm changes.
- Have a history of severe allergic reactions or an allergy to CT3001 or its ingredients. A live vaccine within 4 weeks before treatment also rules you out.
- Use certain medicines that weaken the immune system or are mainly broken down by a liver enzyme called CYP2C8 too close to or during treatment. Do not take stomach-acid reducers from 6 hours before until 2 hours after CT3001.
- Test positive for HIV or certain hepatitis B or C tests. Some people with treated hepatitis B or cured hepatitis C may qualify after review by the study doctors.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. Note: In Phase 2b, only participants with advanced CRC who are eligible for re-engaging FOLFOX will be enrolled. * 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. * Adequate hematologic, liver, and kidney function as follows: Bone marrow reserve: 1. Absolute neutrophil count ≥ 1.5 × 10\^9/L without growth factor support in the 2 weeks prior to study entry. 2. Hemoglobin ≥9.0 g/dL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry. 3. Platelet count ≥ 75 × 10\^9/L without transfusion in 2 weeks prior to study entry. Hepatic function: 1. Serum TBIL \< 1.5 × ULN. 2. AST and ALT \< 3 × ULN. Renal function: Serum creatinine clearance (CrCL) \> 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+; if urine protein \> 2+, 24-hour urinary protein quantity should be measured and must be \< 1.0 g). * 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 months following the last dose of IP. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential; postmenopausal status, if not known, is to be confirmed through testing of follicle-stimulating hormone (FSH) levels of ≥ 40 IU/L. Male participants must be willing not to donate sperm until 3 months following the last IP administration. Exclusion Criteria: * 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, antitumor traditional Chinese Medicine), except during Phase 2b, Standard Care Chemotherapy (FOLFOX-based regimen) for advanced CRC patients is allowed. * 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. Prior use of investigational monoclonal antibody IP can be permitted upon obtaining an approval from the Sponsor. Use of these investigational IP or devices are not permitted for the duration of treatment with 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 participant might require major surgery during the course of the study. * 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 Pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome) or current use of medications that prolong the QTcF interval. * 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 treatment-related complications will be excluded. * 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; these medications will not be permitted for the duration of treatment with 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; these medications will not be permitted for the duration of treatment with 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. * Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibodies (HIV-1/-2) at Screening, unless the participant meets 1 of the following criteria: 1. 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. 2. 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). Please note: the eligibility of patients with HBV or HCV infection should be considered on a case-by-case basis by the PI in consultation with the independent Medical Monitor. * Anything that the PI considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
Study sites (1)
TX
- MD Anderson Cancer Center · Houston, TX 77030Katherine Torres · Study contact · 832-750-4997 · KTorres4@mdanderson.orgJing Peng · Study contact · 713-792-2208 · jingpeng@mdanderson.orgSiqing Fu, MD, PhD · Principal investigatorMore trials in Houston