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

NCT06528249 | Not Yet Recruiting Phase 1

• 1 other identifier: WTX212-002CN
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cancer; Solid Tumor; Hematologic Malignancy

Keywords

Cancer; Solid Tumor; Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of engineered erythrocytes

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Pharmacodynamics characteristics Peak Plasma Concentration(Cmax)

  through study completion, an average of 1 year

• Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC）

  through study completion, an average of 1 year

• Efficacy of Erythrocyte-αPD-1 Conjugate

  per 6 weeks

Other Outcomes (2)

• Anti-drug antibody (ADA)

  through study completion, an average of 1 year

• Peripheral immune response assessment

  through study completion, an average of 1 year

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

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

Dose Expansion

EXPERIMENTAL

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

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 DRUG

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

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
• Regardless of gender, aged 18 to 75 years old (including threshold);
• Patients with advanced malignant tumors who have been confirmed by histopathology;
• 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;
• ECOG≤1；
• Expected life ≥ 3 months；
• 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.

You may not qualify if:

• 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,
• Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
• Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
• There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
• Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
• 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;
• 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

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead
• Westlake Therapeutics: collaborator

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yang Liu, PhD

  ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Yang, PhD

CONTACT

0571-85893889; yangliu@hmc.edu.cn

Study Design

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

Model Details: This is an investigator-initiated, open-label, multicenter, multidose, dose escalation and expansion study to evaluate the safety, tolerability, and efficacy of Erythrocyte-αPD-1 conjugates in patients with advanced malignancies

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 30, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07