Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies

NCT ID: NCT06528249

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-12-31

Brief Summary

This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with advanced malignancies

Detailed Description

This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with unresectable or metastatic advanced malignancies who have failed previous systemic therapy.

The study was divided into two phases: dose escalation and dose expansion

Conditions

Cancer; Solid Tumor; Hematologic Malignancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

Dose Escalation of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy

Group Type: EXPERIMENTAL

Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes

Intervention Type: DRUG

Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes

Dose Expansion

Dose Expansion of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy

Group Type: EXPERIMENTAL

Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes

Intervention Type: DRUG

Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes

Interventions

Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes

Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;

2. Regardless of gender, aged 18 to 75 years old (including threshold);

3. Patients with advanced malignant tumors who have been confirmed by histopathology;

4. Patients with histopathologically confirmed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment;

5. ECOG≤1；

6. Expected life ≥ 3 months；

7. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; Pregnancy testing results for women of childbearing age within ≤ 7 days before the first trial drug administration must be negative. Women of childbearing age include premenopausal women and women within 2 years after menopause.

Exclusion Criteria

1. People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,

2. Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;

3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;

4. There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;

5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.

6. Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;

7. Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Westlake Therapeutics

INDUSTRY

Sponsor Role: collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China

Central Contacts

Liu Yang, PhD

Role: CONTACT

yangliu@hmc.edu.cn

0571-85893889

Other Identifiers

WTX212-002CN

Identifier Type: -

Identifier Source: org_study_id