A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directe… (NCT04467515) | Clinical Trial Compass
TerminatedPhase 1/2
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: Per Strategic Sponsor decision
United States13 participantsStarted 2021-09-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
✓
What they're measuring
1
Dose-limiting Toxicity (DLT) Rate Within the First Cycle
Timeframe: Within the first cycle of CAM-H2, up to 12 weeks
2
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs)
. Adequate organ function, determined by the following laboratory tests:
Exclusion criteria
✕. 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.
✕. 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);