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Trial Title:
Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies
NCT ID:
NCT06528249
Condition:
Cancer
Solid Tumor
Hematologic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Antibodies
Conditions: Keywords:
Cancer
Solid Tumor
Hematologic Malignancy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
Description:
Engineered erythrocytes (or red blood cells) covalently conjugated with commercially
available anti-PD-1 antibodies on their membranes
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 31, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Zhejiang Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Westlake Therapeutics
Agency class:
Industry
Source:
Zhejiang Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06528249
