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Phase 1/2 Clinical Study of HY07121 for Injection (Subcutaneous) in Patients With Advanced Solid Tumors

NCT07789327 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-08-27

No results posted yet for this study

Summary

This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 for Injection (Subcutaneous) in participants with advanced solid tumors.

Conditions

  • Safety
  • Tolerability
  • Efficacy

Interventions

DRUG

Test Product HY07121 for Injection (Subcutaneous)

Dosage form: Powder for solution for infusion. Strength: 10 mg/vial. Method of administration: Subcutaneous administration. Dose escalation: "3+3" dose escalation rules are used to explore the safety and tolerability of the drug HY07121 for Injection (Subcutaneous).Based on emerging clinical data, dose escalation of an SUD-containing regimen may also follow a standard "3+3" design. Dose expansion: according to the preliminary safety and efficacy results of the dose escalation study, an appropriate dose and tumor species for the expansion study are conducted as discussed by the sponsor and investigators to further explore the safety and clinical effectiveness of the drug product HY07121 for Injection (Subcutaneous) and provide a basis for subsequent clinical studies.

DRUG

Test Product HY07121 for Injection (Subcutaneous)

Dosage form: Powder for solution for infusion. Strength: 10 mg/vial. Method of administration: I Subcutaneous administration. Dose escalation: "3+3" dose escalation rules are used to explore the safety and tolerability of the drug HY07121 for Injection (Subcutaneous).Based on emerging clinical data, dose escalation of an SUD-containing regimen may also follow a standard "3+3" design. Dose expansion: according to the preliminary safety and efficacy results of the dose escalation study, an appropriate dose and tumor species for the expansion study are conducted as discussed by the sponsor and investigators to further explore the safety and clinical effectiveness of the drug product HY07121 for Injection (Subcutaneous) and provide a basis for subsequent clinical studies.

Sponsors & Collaborators

  • Sichuan Huiyu Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-08
Primary Completion
2028-04-30
Completion
2028-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789327 on ClinicalTrials.gov