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

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.

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Have received live/attenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live/attenuated vaccines and mRNA vaccines during the study period;
* Any active infection requires systemic treatment via intravenous infusion within 4 weeks prior to the first dose of study treatment;
* Known psychiatric disorder or drug abuse that would interfere the trial requirements;
* Participant with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion or need drainage;
* In addition to the tumors present at the time of entry into the study, other active malignancies were present within 3 years prior to the first dose (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the breast, etc.);
* Participants considered unsuitable for participation in this study by the investigators.

Conditions4

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