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

NCT06639256 | Recruiting Phase 1

• 1 other identifier: HY0007-101
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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 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 or American Society for Transplantation and Cellular Therapy (ASTCT) criteria for Cytokine Release Syndrome (CRS).

  21 days during the first 3-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 Dose Escalation

EXPERIMENTAL

PART ONE- Dose escalation: HY07121 should be administered intravenously at recommended dose. The purpose of the Dose Escalation Phase (Part one) is to characterize the safety and tolerability of the test product HY07121 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

Test product HY07121 for Dose Expansion

EXPERIMENTAL

PART TWO- Dose expansion: HY07121 should be administered intravenously at recommended dose. Patients will be administered a recommended dose of HY07121 established from the Dose Escalation Phase of the study.

Drug: Test Product HY07121

Interventions

Test Product HY07121 DRUG

HY07121 should be administered intravenously at recommended dose.

Also known as: HY0007-101

Test product HY07121 for Dose Escalation; Test product HY07121 for Dose Expansion

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;
• 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;
• 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

Study Sites (1)

Cancer Hospital of Shandong First Medical University

Jinan, China

RECRUITING

Study Officials

• Huiyura666! Yu, Doctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinmin Yu, Doctor

CONTACT

+86-521-67626971; sdyujinming@126.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: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 24, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)