Study of ZGGS34 in Participants With Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
About this trial
This is a multicenter, open-label Phase 1/2 study in participants with advanced solid tumors. The study consists of two parts: Part 1 is a dose-escalation phase to evaluate the safety and tolerability of ZGGS34 in advanced solid tumor participants; Part 2 is a cohort-expansion phase to assess the efficacy and safety of ZGGS34 (± chemotherapy) in selected MUC17-positive advanced solid tumor participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the study and voluntarily sign the informed consent form;
Male or female 18~75 years old.
Archived tumor tissue within 24 months or fresh biopsy specimens must be provided for detection of MUC17 expression, and with positive MUC17 results required.
Disqualifiers
Patients having received any of the following treatments: Prior combination or sequential use of drugs targeting anti-MUC17 (including investigational drugs);Chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and biological targeted medicines ≤ 4 weeks before the first dose. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks before the first dose; Systemic immunosuppressive medications, such as corticosteroid within 14 days prior to the first dose; Use of any live or live attenuated vaccines against viral infections within 4 weeks of first dose.
The investigator considers the subject unsuitable for enrollment in this clinical study for any other reason.
Trial design
Design model
Sequential
Treatments tested in this trial
ZG006
Biological/VaccineZG006 will be administered as an intravenous (IV) infusion.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of dose-limiting toxicity (DLT)
Time frame
Up to 28 days2
Incidence of Treatment-emergent adverse events (TEAEs)
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov