This study is an open-label, multicenter, phase I clinical trial involving dose escalation and dose expansion of ZX-8177 in patients with advanced unresectable, recurrent, or metastatic solid tumors.
The study consists of two stages: dose escalation and dose expansion. It primarily aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and preliminary efficacy of ZX-8177 as a monotherapy with continuous administration in Chinese patients with advanced solid tumors who have failed standard treatment or lack standard treatment options. The study also seeks to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD)/optimal biological dose (OBD), or recommended phase II dose (RP2D).
1. Voluntarily participate in this clinical trial, understand and comply with the study procedures, and voluntarily sign the Informed Consent Form (ICF).
2. No gender restriction, age ≥ 18 years at the time of signing ICF.
3. Minimum expected survival period ≥ 3 months (as determined by the investigator's assessment).
4. ECOG score is 0-1.
1. Previous use of ENPP1 inhibitors or STING agonists.
2. Received anti-tumor drug treatment within 28 days prior to the first administration of the study drug (including small-molecule targeted drugs, oral fluorouracil-based chemotherapy drugs, or modern traditional Chinese medicine preparations approved by the National Medical Products Administration (NMPA) for anti-tumor therapy within 14 days; mitomycin C or nitrosourea-based chemotherapy drugs within 6 weeks), excluding bisphosphonates for bone metastases.
3. History of immune-related adverse events (irAEs) of grade ≥3 during previous immunotherapy.
4. Undergone radiotherapy within 14 days prior to the first administration of the study drug; palliative radiotherapy for the purpose of alleviating local symptoms (non-target lesion irradiation or local administration to non-target lesions) completed within one week before study enrollment is allowed.
Single group
ZX-8177
DrugDose Escalation Phase: The starting dose is 100 mg BID, with a total of 5 predefined dose groups (100 mg BID, 200 mg BID, 400 mg BID, 800 mg BID, and 1200 mg BID).
Participant Safety as characterized by frequency and severity of adverse events
Safety profile including frequency and severity of adverse events that are related to treatment.
In the dose escalation phase, the tolerability metric is to evaluate the incidence of dose related toxicity (DLT).
In the dose escalation phase, the tolerability metric is to evaluate the incidence of DLT.
Changes in CCL4 during the treatment process
Changes in CCL4 during the treatment process
Objective Response Rate (ORR)
Defined as the proportion of patients achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST criteria
Disease Control Rate (DCR)
Defined as the proportion of patients achieving CR, PR, or Stable Disease (SD) as their best overall response.
Duration of Response (DoR)
Applicable only to patients with CR or PR, defined as the time from the first documented response to the date of disease progression (PD) or death.
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