CancerPhase 1NCT06528249
Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies
A Phase 1 study testing Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes in people with Cancer and Solid Tumor, run by Zhejiang Provincial People's Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer, Solid Tumor, Hematologic Malignancy
- What is being tested?
- Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate Injection in Patients With Advanced Malignancies
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
Read the 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
- Being tested
- Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
- Keywords
- Cancer, Solid Tumor, Hematologic Malignancy
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranesDrug
Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Dose Escalation of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy Receives: 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 Receives: Drug: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Pharmacodynamics characteristics Peak Plasma Concentration(Cmax)
The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after infusion,including Peak Plasma Concentration(Cmax)
Measured: through study completion, an average of 1 year
Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC）
The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after infusion,including Area under the plasma concentration versus time curve (AUC).
Measured: through study completion, an average of 1 year
Efficacy of Erythrocyte-αPD-1 Conjugate
According to RECIST 1.1, the effectiveness of Erythrocyte-αPD-1 Conjugate injection in the treatment of patients with unresectable or metastatic advanced solid tumors was evaluated. The evaluation indicators included objective response rate (ORR),etc.
Measured: per 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start31 Jul 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake Therapeutics
- Responsible party
- Sponsor
- Investigators
- Yang Liu, PhD, Principal investigator, ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528249
- Sponsor's protocol ID
- WTX212-002CN
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate Injection in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT06528249
- Acronym / sponsor ID
- WTX212-002CN
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy
- Keywords
- Cancer, Solid Tumor, Hematologic Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Westlake Therapeutics
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranesDose Escalation of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy |
| Dose Expansion | Experimental | Drug: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranesDose Expansion of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranesEngineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Incidence of adverse events
Time frame: through study completion, an average of 1 year
The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of engineered erythrocytes
3 secondary outcomes
Pharmacodynamics characteristics Peak Plasma Concentration(Cmax)
Time frame: through study completion, an average of 1 year
Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC）
Time frame: through study completion, an average of 1 year
Efficacy of Erythrocyte-αPD-1 Conjugate
Time frame: per 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Liu, PhD principal investigator
ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes in people with Cancer and Solid Tumor, run by Zhejiang Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Yang, PhD (0571-85893889, yangliu@hmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.