Phase 1 Pancreatic Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of a solid tumour cancer that has either spread to other parts of the body or cannot be surgically removed, and whose tumour has a specific gene change (called a KRAS mutation — G12V, G12D, G12C, G12R, G12A, or G13D) or a high number of copies of the KRAS gene (4 or more), based on local lab testing.
• For the part of the trial testing the study drug alone (dose escalation): people with any confirmed advanced or metastatic solid tumour who have already received standard treatments that are no longer helping, or for whom standard treatments are not an option.
• For the pancreatic cancer group (dose expansion): people with confirmed advanced or metastatic pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) with one of the listed KRAS gene changes, who have received up to 2 prior rounds of treatment for advanced disease, including gemcitabine- or fluoropyrimidine-based therapy, or for whom those treatments are not suitable.
• For the lung cancer group (dose expansion): people with confirmed advanced or metastatic non-small cell lung cancer (NSCLC) with certain listed KRAS gene changes (G12V, G12D, G12R, G12A, or G13D), who have received standard treatments including platinum-based chemotherapy and immune checkpoint therapy, or for whom those treatments are not suitable.
• For the "other solid tumours" group (dose expansion): people with confirmed advanced or metastatic solid tumours other than pancreatic cancer, colorectal cancer, or lung cancer, with one of the listed KRAS gene changes or high KRAS gene copy number, who have received standard treatments that are no longer helping or for whom standard treatments are not suitable.
• For the colorectal cancer group (combination therapy): people with confirmed advanced or metastatic cancer of the colon or rectum with one of the listed KRAS gene changes, who have received standard treatments including fluoropyrimidine, oxaliplatin, irinotecan, and anti-VEGF therapy, or for whom those treatments are not suitable; those whose tumour has a specific feature called MSI-H or dMMR must also have received immune checkpoint therapy or be ineligible for it.
• People who are willing and able to provide a tumour tissue sample (either an existing stored sample or a new biopsy taken within 90 days before starting the study drug), and who agree to an additional biopsy during treatment (confirm details with trial site if providing a sample is not possible).
• People who have at least one tumour that can be measured using standard imaging criteria.
• People who are generally well enough to carry out daily activities with no or only minor limitations (as assessed by a standard scale called ECOG, score 0 or 1).
• People whose side effects from previous cancer treatments have mostly recovered to mild or pre-treatment levels at least 14 days before starting the study drug (some exceptions may apply — confirm with trial site).
• People whose liver, kidney, and blood counts are within acceptable ranges based on lab tests (blood transfusions must have occurred at least 14 days before these tests).
• Women who are not pregnant (confirmed by pregnancy test and medical assessment) and who either cannot become pregnant, or who agree to use effective contraception from the time of giving consent until at least 6 months after the last dose of the study drug, and who have a negative pregnancy test within 7 days before starting.
• Women who agree not to breastfeed from the screening stage until 6 months after the last dose of the study drug.
• Women who agree not to donate eggs from the first dose of the study drug until 6 months after the last dose.
• Men who agree to use contraception with any female partner(s) who could become pregnant (including those who are breastfeeding) throughout treatment and for 3 months after the last dose.
• Men who agree to remain abstinent or use a condom with any pregnant partner(s) throughout the study period and for 3 months after the last dose.
• Men who agree not to donate sperm during treatment and for 3 months after the last dose.
• People who agree not to participate in any other interventional clinical trial while taking part in this study.
• In Europe only: people who already have local tumour test results available before enrolling.

Who may not be able to join:

• People whose cancer has spread to the brain or spinal cord and is causing symptoms, or has not yet been treated (people with stable, treated, symptom-free brain metastases may still be eligible — confirm with trial site).
• People whose cancer has spread to the thin layers of tissue covering the brain and spinal cord (called leptomeningeal disease).
• People who have had another active cancer (requiring treatment) within the past 2 years, other than certain low-risk skin cancers, superficial bladder cancer, or early-stage cervical or breast cancer that has been treated and appears cured.
• People with active hepatitis B or active hepatitis C (detected by a specific blood test).
• People with a known history of HIV infection that has progressed to AIDS-related complications.
• People who have had a heart attack or unstable chest pain within the 6 months before starting the study, or who currently have uncontrolled heart conditions such as heart failure, significant irregular heartbeat, or a condition called long QT syndrome, among others.
• People with a resting heart rate below 50 beats per minute at screening, unless a doctor determines this is not clinically significant (confirm with trial site).
• People with a known family history of sudden cardiac death before the age of 50.
• People with low potassium levels in the blood that cannot be corrected to normal before the first dose.
• People with other significant abnormal electrolyte levels (such as low magnesium or calcium) that cannot be corrected to normal before the first dose.
• People who have had major surgery within 4 weeks before the first dose.
• People who have had a serious neurological event (such as a stroke or brain bleed) within 6 months before the first dose.
• People who have received any radiotherapy (including targeted radiation to the brain) within 14 days before the first dose.
• People who have previously received treatments that specifically target the KRAS gene (such as KRAS inhibitors, certain gene-silencing therapies, vaccines, or cell-based therapies), with some limited exceptions in the dose escalation part for pancreatic or lung cancer patients who received specific prior drugs (confirm with trial site).
• People who have an active infection requiring systemic treatment (such as antibiotics or antifungals) within 14 days before starting the study drug.
• People who are expected to need another cancer treatment at the same time as the study treatment.
• People who need to take certain other medications that strongly or moderately affect how the body processes a specific liver enzyme pathway (called CYP3A), as these could interfere with the study drug.
• People who have received any other experimental therapy within 28 days or 5 half-lives (whichever is longer) before screening.
• People with any condition that the trial site determines makes participation unsafe or unsuitable.
• People with a known or suspected allergy or sensitivity to the study drug or any of its ingredients.
• People with a specific heart electrical reading (QTcF interval) above a certain threshold on an ECG during screening (above 450 milliseconds for men, or above 470 milliseconds for women).
• People whose heart pumping function (left ventricular ejection fraction) is below 50% as measured by a heart scan (echocardiogram or similar) at screening.
• People whose specific KRAS gene change is known to have developed as a way the cancer became resistant to a previous treatment (with some nuances depending on the number and type of KRAS changes present — confirm with trial site).
• In Europe only: people who are subject to any legal protection measures under local law.
• People with a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease), or who currently have these conditions (people with fully resolved lung infections may still be eligible).
• For the combination therapy part only: people who previously had to stop taking a drug called panitumumab due to side effects or intolerance.

Important: Always verify eligibility with the trial site directly before applying.