Clinical trial NCT06528249: Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies
Official title: Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate Injection in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Cancer
Solid Tumor
Hematologic Malignancy
Keywords: Cancer
Solid Tumor
Hematologic Malignancy
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Westlake Therapeutics
First posted: 2024-07-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Pharmacodynamics characteristics Peak Plasma Concentration(Cmax)
timeFrame: through study completion, an average of 1 year
measure: Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC）
timeFrame: through study completion, an average of 1 year
measure: Efficacy of Erythrocyte-αPD-1 Conjugate
timeFrame: per 6 weeks
Other outcomes:
measure: Anti-drug antibody (ADA)
timeFrame: through study completion, an average of 1 year
measure: Peripheral immune response assessment
timeFrame: through study completion, an average of 1 year
Locations:
Study officials:
affiliation: ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China
name: Yang Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: