A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment

In brief

This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients with progressive, advanced/metastatic HER2-positive breast, gastric, and GEJ cancer with disease progression following anti-HER2 standard of care treatment.

Key facts

Study ID

NCT04467515

Run by

Precirix

People needed

13

Starts

2021-09-14

Expected to finish

2023-12-11

Last updated by the study team

2025-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent form signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required for, the study and is willing to participate in the study;
• Males and females ≥ 18 years of age at screening;
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1;
• HER2-positive locally advanced or metastatic breast cancer refractory to standard cancer treatment or HER2-positive locally advanced or metastatic gastric or GEJ cancer, refractory to standard cancer treatment.
• Patients should have a minimum of 1 measurable lesion as defined by RECIST version 1.1 or a minimum of 1 measurable lesion as defined by RANO-BM within 4 weeks of the first dose of the study drug (Day 1). The lesion has to be a new lesion or progression of an existing lesion under the current therapy.
• Any previous anti-HER2 treatment for advanced or metastatic disease is allowed. Patients with breast cancer should have had at least 2 previous systemic anticancer treatments for recurrent, locally advanced or metastatic cancer. Patients with gastric cancer or GEJ cancer should have had at least 1 previous anti-HER2 treatment.
• Life expectancy > 6 months;
• Adequate organ function, determined by the following laboratory tests:
• Adequate kidney function with an estimated glomerular filtration rate (eGFR) of >59 mL/minute calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
• Adequate hepatic function defined as an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x the upper limit of normal (ULN), or <5 x ULN in patients with liver metastases, and total bilirubin <2 x ULN;
• Neutrophil count >1500 cells/mm3 without growth factor support (14 days after last PEGylated granulocyte colony stimulating factor or 7 days after regular granulocyte colony stimulating factor);
• Platelet count >100,000 cells/mm3 without platelet transfusion in the last 2 weeks;
• Hemoglobin >9.0 g/dL without blood transfusion in the last 2 weeks; and
• Adequate coagulation defined as an international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time <1.5 x the upper limit of the institutional normal range;
• Baseline left ventricular ejection fraction ≥ 50% as measured by echocardiography or multigated acquisition scan.
• Absence of any psychological, family, sociological, or geographical circumstance that could potentially represent an obstacle to compliance with the study protocol and the follow-up schedule, as determined by the Investigator. These circumstances will be discussed with the patient before enrollment in the study; and
• Female patients of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) must have a negative pregnancy test at screening and prior to study drug administration. Patients and their partners of childbearing potential must be willing to use 2 methods of contraception, 1 of which must be a barrier method, for the duration of the study and until 6 months after study drug administration. Medically acceptable barrier methods include condom with spermicide or diaphragm with spermicide. Medically acceptable non-barrier contraceptive methods include intrauterine devices or hormonal contraceptives (oral, implant, injection, ring, or patch).

You may not qualify if…

• Presence of frank leptomeningeal disease as a unique central nervous system feature or in association with brain parenchymal measurable lesion(s);
• Symptomatic brain metastases; Note: Patients with asymptomatic treated and untreated brain metastases are eligible.
• Previous local therapy for brain metastases, such as neurosurgery, stereotactic radiotherapy, or whole brain radiotherapy, administered within 6 weeks prior to administration of CAM-H2; Note: Previous therapy for brain metastases administered at least 6 weeks prior to CAM-H2 administration will be allowed.
• For patients with brain metastases, any increase in corticosteroid dose during the 4 weeks prior to the first administration of CAM-H2.
• Note: Corticosteroid treatment in a stable dose or decreasing dose for at least 4 weeks prior to the first administration of CAM-H2 is allowed.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements;
• Uncontrolled thyroid disease, defined as free triiodothyronine (T3) and free thyroxine (T4) > 3 x ULN at screening;
• Uncontrolled diabetes defined as a fasting serum glucose > 2 x ULN or glycated hemoglobin levels > 8.5% at screening;
• Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (eg, Crohn's, ulcerative colitis);
• Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment);
• Ongoing peripheral neuropathy of Grade > 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0;
• Severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
• Symptomatic congestive heart failure of New York Heart Association Class III or IV;
• Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; or
• Liver disease, including cirrhosis and severe hepatic impairment;
• Active (acute or chronic) or uncontrolled severe infections;
• Known history of HIV, hepatitis B, or active hepatitis C virus at screening;
• Prior investigational anticancer therapy within 4 weeks prior to the first administration of CAM-H2.
• Patients who have had a major surgery or significant traumatic injury within 4 weeks prior to the first administration of CAM-H2, who have not recovered from side effects of any major surgery (defined as requiring general anesthesia), or have a major surgery planned during the course of the study;
• Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin or stage I uterine cancer;
• Radiation therapy for metastatic disease foci outside the brain, administered within 3 weeks prior to the first administration of CAM-H2;
• Known hypersensitivity to any of the study drugs (including inactive ingredients), including iodine allergy;
• History of significant comorbidities that, in the Investigator's judgement, may interfere with study conduct, response assessment, or informed consent;
• Unable or unwilling to complete the study procedures;
• Patients that cannot be hospitalized in a radionuclide therapy room;

Where it is running

• City of Hope — Duarte, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Advanced Molecular Imaging & Therapy — Glen Burnie, Maryland, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Hospital Notre Dame du CHUM — Montreal, Quebec, Canada
• McGill University Faculty of Medicine - Royal Victoria Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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