Study of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors (NCT05423977) | Clinical Trial Compass
By InvitationPhase 1
Study of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors
China36 participantsStarted 2021-12-17
Plain-language summary
An open-label, multicenter, phase I dose-escalation study to assess the safety, Pharmacokinetic (PK), immunogenicity and preliminary anti-tumor activity of ZV0203 in patients with HER2-Positive advanced solid tumors
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Being willing and capable of signing a written informed consent form (ICF).
✓. Aged ≥18 or older at the time of signing the ICF.
✓. Pathologically diagnosed as having an unresectable locally advanced or metastatic solid tumors, refractory or intolerant to standard therapy, or with no standard therapy available.
✓. Having HER2-positive disease, i.e. HER2 positive by in situ hybridization on previously collected tumor tissue and/or immunohistochemistry of 3+.
✓. The Eastern Cooperative Oncology Group Performance Status (ECOG) performance status score is 0 or 1.
✓. Echocardiography (ECHO) or multi-gated acquisition (MUGA) scan shows a left ventricular ejection fraction of ≥ 50%.
✓. Good hematology and end-organ function, with laboratory results within 14 days prior to the first study treatment (Cycle 1, Day 1) meeting the following criteria:
✓. The investigator determined that the life expectancy of the subjects is ≥12 weeks.
Exclusion criteria
✕. Subjects with symptomatic brain metastases or soft meningeal disease known to require steroid therapy. Subjects diagnosed with brain metastases in the past can participate in the study if they have completed the treatment, recovered from the acute reaction of radiotherapy or surgery prior to enrollment, have discontinued the use of corticosteroids for the treatment of these metastases, and have been clinically stable and neurologically stable without anticonvulsants for at least 4 weeks prior to enrollment.
What they're measuring
1
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: From the day of ICF sign to 30 days after the day of the last treatment
. Subjects who are suffering from uncontrolled or major cardiovascular disease, including any of the following circumstances:
✕. Subjects who have a history of clinically significant lung disease (e.g., interstitial pneumonia, pulmonary fibrosis, and severe radiation pneumonia) or suspicion of these diseases by imaging at screening.
✕. Subjects who have a history of ocular abnormalities and judged to be ineligible for enrollment by the investigator.
✕. Subjects who have received any anticancer treatment or investigational therapy within 4 weeks prior to the first dose of ZV0203.
✕. Subjects who have received hormone therapy within 14 days prior to the first dose of ZV0203, except hormone therapy for non-cancer related conditions (e.g. alternative therapies of insulin and hormone for diabetes).
✕. Subjects who have undergone major surgery or scheduled surgery for any reason within 4 weeks prior to screening or those the investigator believe may require surgery.
✕. Toxicity of prior anticancer therapy does not improve to NCI-CTCAE V5.0 Grade 0 or 1, except for alopecia and laboratory values listed according to the inclusion criteria.