Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan Huiyu Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

Written informed consent;

≥18 years old and ≤80 years old, gender: male or female;

Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available;

Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1;

Disqualifiers

Within the defined washout periods for prior anti-cancer treatments;

Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.

Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.

Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).

Trial design

Treatments tested in this trial

  • Test Product HY07121

Treatment groups

258 Participants
are divided into 2 treatment groups