Clinical Trials

Inclusion Criteria - For Roll-over Patients from Trial HS-18-633:

• Patients who attend the Week 24 visit of the preceding trial (HS-18-633) and are willing to continue their participation in this trial.
• Written informed consent of the patient.
• Patients must be willing to use an acceptable method of contraception during the entire trial.

Inclusion Criteria - For New Patients:

• Able to provide written informed consent to participate in the trial prior to any
  trial-related procedures are performed .
• Willingness and ability to comply with the requirements of the protocol.
• Male or female patients, ≥ 18 years at screening.
• Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
  as documented by:
  • IGF-1 levels > 1 x ULN;
  • Pituitary adenoma on magnetic resonance imaging (MRI) or pathology report Computerized tomography (CT) is accepted if MRI could not be performed;
  • IGF-1 levels >1 x ULN measured at least 3 months after the surgery for patients who have undergone pituitary surgery.
• Treatment with a stable dose of octreotide LAR (10 mg, 20 mg, 30 mg or 40 mg) or
  lanreotide ATG (60 mg, 90 mg or 120 mg) for at least 3 months as monotherapy prior to
  screening.
• IGF-1 levels >1 x ULN and ≤ 2.0 x ULN at screening (adjusted for age and sex; mean
  value of the first measurement at screening and the second measurement at 2 weeks
  before Day 1) with or without prior pituitary radiotherapy (at least 3 years prior to
  screening), or IGF-1 levels ≤ 1 x ULN at screening (adjusted for age and sex; mean value of the first measurement at screening and the second measurement at 2 weeks before Day 1), with prior pituitary radiotherapy at least 3 years prior to screening and confirmed disease activity defined as IGF-1 levels > 1 x ULN during drug holiday 3 to 9 months prior to
  screening.
• Patients must have adequate liver, pancreatic, renal and bone marrow functions:
  • Adequate liver function:
    • Total serum bilirubin ≤ 1.5 x ULN*;
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x ULN;
    • International normalized ratio (INR) < 1.3.
  • Adequate pancreatic function:
    • Amylase and lipase ≤ 2 x ULN.
  • Adequate renal function:
    • Estimated glomerular filtration rate ≥ 60 mL/min by the Modification of Diet in Renal Disease formula.
  • Adequate bone marrow function:
    • Platelets ≥ 100 x 10^9/L;
    • Hemoglobin > 9 g/dL;
    • White blood cells > 3.0 x 10^9L.

*Patients with previous diagnose of Gilbert’s syndrome may be included if the disease is not
accompanied by other hepatobiliary disorders and if the total bilirubin is < 3 mg/dL
(< 51.3 μmol/L) and the direct bilirubin is ≤ ULN.

• Normal ECG defined as the following as determined by the mean value of a triplicate ECG:
  • Resting heart rate 50-105 bpm;
  • QTc interval corrected by Fridericia’s formula (QTcF) <450 msec.
• Female patients of childbearing potential must be willing to use an acceptable method of contraception during the entire trial.
• Male patients must be willing to use condoms throughout the trial unless they have been sterilized by vasectomy (with an appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).

Exclusion Criteria:

For Roll-over Patients from Trial HS-18-633

• Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633).
• Patients who, based on the Investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation. Conditions may include cardiovascular, peripheral vascular, pulmonary, hepatic, renal, or neurological disease, as determined by physical examination, laboratory tests or ECG.
• Pregnancy.

For New Patients

• Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer]).
• Currently receiving other treatments known to affect GH or IGF-1 concentration (including oral estrogens for e.g. contraception or replacement treatment in hypogonadism or during menopause).
• Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks).
• Compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
• Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening. Patients who have undergone surgery more than 1 month from screening must have recovered from the treatment and be in good clinical condition.
• Patients who have undergone pituitary surgery within 6 months prior to screening
• Patients who have received prior pituitary irradiation within 3 years prior to screening
• A history of another primary malignancy except the following:
  • Stable and well-differentiated microcarcinoma of the thyroid
  • Non-melanoma skin cancer, and carcinoma in situ of the cervix, uterus, or breast from which the patient has been disease-free for ≥3 years
  • A primary malignancy that has been completely resected and in complete remission for ≥5 years.
• Participation in any other clinical trial to test an investigational drug or device within the last 30 days before screening
• Patients with poorly controlled diabetes mellitus, defined as hemoglobin A1c (HbA1c) >8.0%
• Patients with diabetes mellitus who have initiated treatment with insulin or who have changed the insulin treatment regimen within 6 weeks prior to screening
• Hepatic/pancreatic-related exclusion criteria
  • Presence of hepatitis B surface antigen
  • Current hepatitis C virus infection
  • History of alcohol/drug misuse within the past 12 months
  • Patients with symptomatic cholelithiasis within 3 months from screening (patients with non-symptomatic cholelithiasis/sludge and patients who have undergone cholecystectomy more than 1 month from screening can be included in the trial)
• Patients with presence of active or suspected acute or chronic uncontrolled infection or
• immunocompromised patients, including patients with positive human
• immunodeficiency virus (HIV) test result
• Cardiac exclusion criteria: cardiac or cardiac repolarization abnormality, including any
• of the following:
  • a. History of myocardial infarction, angina pectoris or coronary artery bypass graft
  • within 6 months prior to screening
  • b. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete
  • left bundle branch block, high-grade atrioventricular (AV) block (e.g. bifascicular
  • block, Mobitz type II and third-degree AV block)
  • c. Long QT syndrome, family history of idiopathic sudden death or congenital long
  • QT syndrome, or any of the following:
  • i. Risk factors for Torsades de Pointes including uncorrected hypokalemia or
  • hypomagnesemia, history of cardiac failure or history of clinically
  • significant/symptomatic bradycardia
  • ii. Concomitant medication(s) with a “Known risk of Torsades de Pointes” that cannot be discontinued or replaced by
  • safe alternative medication/s. A wash-out of 5 half-lives or 7 days
  • (whichever is longer) from previous treatment with drugs with a known
  • risk of Torsades de Pointes is required prior to the first dose of CAM2029
  • iii. Inability to determine the QTcF interval
• Uncontrolled hypertension defined by a systolic blood pressure >160 mmHg and/or
• diastolic blood pressure >100 mmHg. The patient needs to be on a stable dose of
• antihypertensive medication for at least 4 weeks before screening
• Untreated or uncontrolled hypothyroidism, hypoadrenalism or diabetes insipidus.
• Patients must be adequately treated with stable doses of replacement therapy for a
• minimum of 3 months prior to screening
• Any other current or prior medical condition that may interfere with the conduct of the
• trial or the evaluation of its results in the opinion of the Investigator or the Sponsor’s
• Medical Monitor
• Pregnant, lactating or planning to be pregnant during the trial
• Clinically significant laboratory abnormalities, which in the opinion of the Investigator
• may prevent the patients from safely participating in the trial
• Any known allergy, hypersensitivity or intolerance to octreotide or any related drug, or
• history of any drug hypersensitivity or intolerance which in the opinion of the
• Investigator, would compromise the safety of the patient or the trial
• Any other contraindicated serious medical condition, which in the opinion of the
• Investigator may prevent the patients from safely participating in the trial.
• Unwilling or unable to comply with the requirements of the protocol or in a situation or  condition that, in the opinion of the Investigator, may interfere with participation in the trial.
• On the staff, affiliated with, or a family member of the personnel directly involved with this trial.