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A Phase 1/2 Trial of the Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss
EU CTIS ID: 2024-518177-33-00
What this study is testing
Determine point estimates of activity of ART27.13 in terms of weight gain, lean body mass, KPS, and improvement of anorexia at the Stage 2 doses at 4, 8, and 12 weeks with intrapatient dose escalation at 4-week intervals. Those patients who are enrolled prior to the design changes being implemented will be dosed at a stable dose of 650µg for the entire 12 week duration.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Have cancer (except those excluded by the exclusion criteria) documented by histopathology or cytology.
- Understand and voluntarily sign and date an Informed Consent Document (ICD) prior to any study related assessments/procedures.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Agree to not driving or operating heavy machinery for the first 4 weeks of treatment or longer if AEs warrant, as known AEs of ART27.13 include dizziness and somnolence.
- Have anorexia as determined by self-reported decrease or lack of appetite or aversion to food.
- Have documented, unintentional weight loss of >5% of body weight and a continuous downward trend of weight loss in the past 6 months (± 2 weeks) dating back from the date of enrollment.
You likely can't join if
- Primary brain tumors or symptomatic brain metastases.
- Known hypersensitivity to ART27.13 or any of its excipients. A list of ingredients of ART27.13 capsules will be provided to sites prior to the start of Stage 1 of the protocol. Prior to the start of Stage 2, the list of ingredients will be provided for placebo.
- Pregnant or breast feeding.
- Clinically significant, recent depression requiring the start of antidepressant medications within 4 weeks prior to enrollment. Patients who are already stable on antidepressant medication are permitted.
- Condition other than cancer that is active and causing anorexia and/or weight loss such as AIDS, chronic obstructive pulmonary disease, chronic kidney disease, heart failure, or pathological eating disorder.
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics & psychiatric illness/social situations that would limit compliance with study requirements.
See the full eligibility criteria
Who can join
- Have cancer (except those excluded by the exclusion criteria) documented by histopathology or cytology.
- Understand and voluntarily sign and date an Informed Consent Document (ICD) prior to any study related assessments/procedures.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Agree to not driving or operating heavy machinery for the first 4 weeks of treatment or longer if AEs warrant, as known AEs of ART27.13 include dizziness and somnolence.
- Have anorexia as determined by self-reported decrease or lack of appetite or aversion to food.
- Have documented, unintentional weight loss of >5% of body weight and a continuous downward trend of weight loss in the past 6 months (± 2 weeks) dating back from the date of enrollment.
- Patients are on either: no anti-cancer therapy for the 2 weeks before enrollment and are not expected to have anti-cancer therapy for the first 12 weeks after the first dose of ART27.13 (Stage 1) or if in Stage 2, after the start of ART27.13/placebo OR stable dosing from 2 weeks before enrollment and expected to be on such therapy for another 12 weeks of anti-cancer therapies.
- Estimated life expectancy of at least 12 weeks as judged by the Investigator based on clinical impression.
- Have a KPS of > 50
- At least 18 years of age at the time of enrollment.
- Adequate hematological, renal, and hepatic function based on laboratory values obtained within 14 days of randomization: • Absolute neutrophil count ≥ 1.0 × 109/L • Platelets ≥ 75 × 109/L • Serum creatinine ≤ 1.5 times upper limit of laboratory normal (ULN) • Total serum bilirubin ≤ 1.5 times ULN (≤ 3.0 times ULN if patient has been diagnosed with Gilbert’s syndrome or liver metastases) • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (AP) ≤ 2.5 times ULN (≤ 5.0 times ULN if the patient has been diagnosed with liver metastases)
- For women of child-bearing potential and for men with partners of child-bearing potential, patient must agree to take contraceptive measures for duration of treatments and for 6 months after last study treatment.
What rules you out
- Primary brain tumors or symptomatic brain metastases.
- Known hypersensitivity to ART27.13 or any of its excipients. A list of ingredients of ART27.13 capsules will be provided to sites prior to the start of Stage 1 of the protocol. Prior to the start of Stage 2, the list of ingredients will be provided for placebo.
- Pregnant or breast feeding.
- Clinically significant, recent depression requiring the start of antidepressant medications within 4 weeks prior to enrollment. Patients who are already stable on antidepressant medication are permitted.
- Condition other than cancer that is active and causing anorexia and/or weight loss such as AIDS, chronic obstructive pulmonary disease, chronic kidney disease, heart failure, or pathological eating disorder.
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics & psychiatric illness/social situations that would limit compliance with study requirements.
- Major surgery within 2 weeks prior to enrollment.
- Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator or Medical Monitor.
- Known human immunodeficiency virus infection, acute or chronic hepatitis B, or acute hepatitis C infection.
- Clinically significant ascites requiring or expected to require paracentesis.
- Corrected QT intervals (QTc) intervals calculated according to Fridericia’s formula (QTcF) >480 ms.
- Unable to swallow food or medication capsules.
- Anticipated need for anti-cancer therapy from 2 weeks prior to enrollment and 12 weeks after the first dose of ART27.13 or in Stage 2 ART27.13/placebo. (Continued use of certain anti-cancer therapy is allowed)
- Investigational agent within 4 weeks prior to enrollment or expected need for an investigational agent for 12 weeks after the first dose of ART27.13 or in Stage 2 placebo.
- Receiving radiotherapy within 2 weeks dating back from enrollment or anticipated to need radiotherapy within 12 weeks of enrollment. Short term palliative radiation treatment involving a local lesion is allowed.
- Patients who have previously participated in a study with ART27.13 would be excluded. Patients who fail screening can be rescreened a maximum of 1 time if the Investigator believes that the reason for screen failure may resolve
- Patients with oral mucositis or oral fungal infection causing anorexia or impairing taste.
- Have a disorder that causes obstruction of the gastrointestinal tract or limits the absorption of calories such as bowel obstruction or celiac disease.
- Receiving tube feedings or parenteral nutrition.
- Be on, been on within 4 weeks prior to enrollment, or expected to be on medications that have the potential to affect anorexia or caloric intake. Examples of such medications include any synthetic or natural cannabinoid (inhaled or administered by any other route) and megestrol.
- Be on, been on within 4 weeks prior to enrollment, or expected to be on medications that are known to be strong cytochrome P450 (CYP3) A4 inhibitors or inducers
- Corticosteroids are allowed if on a stable or tapering dose for 2 weeks prior to enrollment. Patients taking inhaled corticosteroids are permitted.
- History of any recreational or illicit drug use, alcohol misuse, or other drug misuse within the last 24 months. Current illicit drug use or recreational or medicinal use of cannabinoids is also excluded.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.