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

NCT07789327 | Not Yet Recruiting Phase 1

• 1 other identifier: HY0007-SC-101
• Study Type: interventional
• Target: 254
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)

  Dose-Limiting Toxicity (DLT) will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  28 days during the first 4-week cycle

• Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

  Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

  Up to 2 years

• Dose Escalation (Part One): Percentage of participants experiencing Adverse Event (AE) related dose interruptions, dose delays, and dose intensity

  Occurrence of Adverse Event (AE) related dose interruptions, dose delays and dose intensity (duration of HY07121 exposure)

  Up to 2 years

• Dose Expansion (Part Two): Objective Response Rate (ORR)

  Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR)

  Up to 2 years

Secondary Outcomes (13)

• Dose Expansion (Part Two): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

  Up to 2 years

• Dose Expansion (Part Two): Percentage of participants experiencing adverse event (AE) related dose interruptions, dose delays, and dose intensity

  Up to 2 years

• Dose Escalation and Expansion: Assessment of HY07121 Cmax

  Up to 2 years

• Dose Escalation and Expansion: Assessment of HY07121 AUC

  Up to 2 years

• Dose Escalation and Expansion: Assessment of HY07121 T1/2

  Up to 2 years

Study Arms (2)

: Test product HY07121 for Injection (Subcutaneous) for Dose Escalation

EXPERIMENTAL

PART ONE- Dose escalation: HY07121 for Injection (Subcutaneous) should be administered Subcutaneously at recommended dose. The purpose of the Dose Escalation Phase (Part one) is to characterize the safety and tolerability of the test product HY07121 for Injection (Subcutaneous) and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) based on the frequency of the occurrence of Dose-Limiting Toxicity (DLT) in each cohort during the DLT evaluation period.

Drug: Test Product HY07121 for Injection (Subcutaneous)

Test product HY07121 for Injection (Subcutaneous) for Dose Expansion

EXPERIMENTAL

PART TWO- Dose expansion: HY07121 for Injection (Subcutaneous) should be administered Subcutaneously at recommended dose. Patients will be administered a recommended dose of HY07121 for Injection (Subcutaneous) established from the Dose Escalation Phase of the study.

Drug: Test Product HY07121 for Injection (Subcutaneous)

Interventions

Test Product HY07121 for Injection (Subcutaneous) DRUG

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.

Also known as: HY0007-SC-101

: Test product HY07121 for Injection (Subcutaneous) for Dose Escalation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• ≥18 years old and ≤80 years old, gender: male or female;
• Dose escalation part: cytologically or histopathologically confirmed locally advanced or advanced solid tumor that has failed standard therapy, or for which no standard therapy exists, or for which standard therapy is not tolerated or has been refused (for tumor types for which PD-1/PD-L1-related inhibitors are approved in China, failure of prior PD-1/PD-L1-related inhibitor therapy is required). Solid tumors in the dose expansion part include non-small cell lung cancer (driver gene-negative), gastric cancer, esophageal cancer, Microsatellite Instability-High / Mismatch Repair-Deficient Solid Tumors (MSI-H/dMMR) solid tumors, cervical cancer, non-muscle-invasive bladder cancer, head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma), renal cell carcinoma, and other tumor types;
• Dose escalation part: at least one evaluable tumor lesion is required. Dose expansion part: at least one measurable tumor lesion is required (per RECIST v1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
• Life expectancy ≥3 months;
• Participant must have adequate main organ function;
• Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study.
• Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.

You may not qualify if:

• 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).
• Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;
• Major surgery within 4 weeks of receiving the first dose of study treatment;
• Participant has Symptomatic Central Nervous System (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 4 weeks of first dose of study treatment;
• Participants with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included;
• Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; or uncontrolled hypertension;
• Known Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS);
• Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test;
• Active known or suspected autoimmune disease.
• History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease;
• History of severe allergy;
• History of allogeneic organ transplantation or graft-versus-host disease;

Sponsors & Collaborators

• Sichuan Huiyu Pharmaceutical Co., Ltd: lead

MeSH Terms

Interventions

Injections; Injections, Subcutaneous

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jinmin Yu, Doctor

CONTACT

+86-521-67626971; sdyujinming@126.com

Hongxu Liu, Doctor

CONTACT

+86-024-81916200; liuhongxu3366@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 8, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08