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NOT YET RECRUITING
NCT07789327
PHASE1/PHASE2

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

Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Official title: An Open-label, Multiple-center, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 for Injection (Subcutaneous) in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

254

Start Date

2026-09-08

Completion Date

2028-10

Last Updated

2026-08-27

Healthy Volunteers

No

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.