Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Advanced Solid Tumors

NCT07310134 | Recruiting Phase 1

• 2 other identifiers: ZX-8177-201CTR20254582
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Advanced Solid Tumors

Keywords

advanced solid tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 30 days following last dose.

• 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.

  Up to 28 days following first dose.

Secondary Outcomes (20)

• Changes in CCL4 during the treatment process

  Up to 30 days following last dose.

• Objective Response Rate (ORR)

  Up to 14 days following last dose.

• Disease Control Rate (DCR)

  Up to 14 days following last dose.

• Duration of Response (DoR)

  Up to 14 days following last dose.

• Progression-Free Survival (PFS)

  Up to 14 days following last dose.

Study Arms (1)

Dose escalation

EXPERIMENTAL

Dose Escalation Phase: The specific design is as follows: 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).

Drug: ZX-8177

Interventions

ZX-8177 DRUG

Dose 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).

Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily participate in this clinical trial, understand and comply with the study procedures, and voluntarily sign the Informed Consent Form (ICF).
• \. No gender restriction, age ≥ 18 years at the time of signing ICF.
• \. Minimum expected survival period ≥ 3 months (as determined by the investigator's assessment).
• \. ECOG score is 0-1.
• \. Advanced malignant tumors confirmed by histology/cytology: Advanced solid tumors without standard effective treatment options, or those that are ineffective or recurrent after standard treatment, or intolerant to standard treatment, or for which standard treatment is not applicable at this stage.
• \. The subject must have at least one measurable lesion defined by RECIST v1.1, which has not been previously irradiated or has shown clear disease progression after radiotherapy.
• Adequate Organ Function:
• Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min \[Cockcroft-Gault formula: (\[140 - age\] × weight \[kg\] × \[0.85 for females only\]) / (72 × creatinine (mg/dl))\]; qualitative urine protein ≤ 1+; if qualitative urine protein ≥ 2+, a 24-hour urine protein quantification test is required, and a result of \<1 g is acceptable.
• Hepatic: AST and ALT ≤ 2.5 × ULN (for subjects with liver involvement, AST and ALT ≤ 4 × ULN); total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin ≤ 3 × ULN). Coagulation function: For subjects not receiving anticoagulant therapy, the International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN.
• Bone Marrow: Absolute neutrophil count (ANC) \> 1.5 × 10⁹/L; hemoglobin level ≥ 90 g/L; platelet count ≥ 90 × 10⁹/L (administration of medications with leukocyte/platelet-boosting effects within 14 days prior to enrollment to meet eligibility criteria is not permitted).
• \. Female patients of childbearing potential must have a negative serum pregnancy test during screening. Female patients not of childbearing potential (meeting at least one of the following criteria):
• Have undergone hysterectomy or bilateral oophorectomy/salpingectomy, or
• Have medically confirmed ovarian failure, or
• Are medically confirmed to be physiologically postmenopausal (with amenorrhea for at least 12 consecutive months, excluding causes such as chemotherapy, radiotherapy, or the use of estrogen/progestin therapy or other pathological factors).
• \. Females of childbearing potential and male partners of females of childbearing potential must agree to use effective contraception during the study and for 6 months (for females) or 3 months (for males) after the last dose of ZX-8177:

You may not qualify if:

• \. Previous use of ENPP1 inhibitors or STING agonists.
• \. 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.
• \. History of immune-related adverse events (irAEs) of grade ≥3 during previous immunotherapy.
• \. 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.
• \. Participation in any other interventional clinical trials within 1 month prior to enrollment or within less than 5 half-lives (except for subjects who have completed other clinical studies and are only undergoing subsequent survival follow-up).
• \. History of any organ transplantation, including allogeneic stem cell transplantation, except for transplants that do not require immunosuppression (e.g., corneal transplantation, hair transplantation).
• \. Major surgery requiring general anesthesia, liver ablation, or hepatic arterial intervention within 28 days before the first administration of the investigational drug; or surgery requiring local/epidural anesthesia within 2 weeks prior to starting the investigational drug; or the subject has planned surgery or is considered by the investigator to require surgery; or unresolved postoperative complications before dosing (major surgery is defined as procedures under general anesthesia or involving significant incisions);
• \. Adverse reactions from prior anti-tumor therapy or complications/sequelae from surgery \> Grade 1 or not resolved to baseline (CTCAE v5.0, except alopecia or other toxicities deemed by the investigator to pose no safety risk to the subject);
• \. Administration of live, inactivated, or attenuated vaccines within 30 days before the first dose of the investigational drug; examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, COVID, bacillus Calmette-Guérin (BCG), and typhoid vaccines; inactivated or attenuated vaccines such as injectable seasonal influenza vaccines, intranasal influenza vaccines (e.g., FluMist®), etc.;
• \. Subjects with symptomatic central nervous system metastases or carcinomatous meningitis (including leptomeningeal carcinomatosis); if CNS metastases are present, they must be assessed by the investigator as asymptomatic and stable for at least 3 months.
• \. History of another malignancy within the past 5 years, except malignancies treated with surgery alone and in continuous disease-free survival; except early-stage in situ carcinoma after resection;
• \. Uncontrolled electrolyte disturbances (e.g., hypocalcemia, hypomagnesemia, hypokalemia);
• \. Dysphagia;
• \. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites;
• \. Systemic use of immunosuppressive doses (prednisone \>10 mg/day or equivalent) of medications (e.g., corticosteroids) within 2 weeks before starting the investigational drug, excluding topical glucocorticoids via nasal spray, inhalation, or other local routes, or physiological doses of systemic glucocorticoids (i.e., not exceeding 10 mg/day prednisone or equivalent of other glucocorticoids);

Sponsors & Collaborators

• Nanjing Zenshine Pharmaceuticals: lead

Study Sites (1)

Shanghai GoBroad Cancer Hospital

Shanghai, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 30, 2025
• Study Start: December 26, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)