Trials Sponsors Conditions Drugs Pricing

Conditions

Adult Solid Tumor

Keywords

oncolytic virusesPD-1

Outcome Measures

Primary Outcomes (1)

Incidence of treatment-related AEs
Treatment-related AEs are defined as any adverse medical events occurring since the initiation of treatment and grading these toxicities by Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Up to 12 months since the initiation of treatment.

Secondary Outcomes (6)

DCR
Up to 2 years since the initiation of treatment.
ORR
Up to 2 years since the initiation of treatment.
DOR
Up to 5 years since the initiation of treatment.
PFS
Up to 5 years since the initiation of treatment.
OS
Up to 5 years since the initiation of treatment.
+1 more secondary outcomes

Other Outcomes (2)

Immunological response
PB samples are collected at least on days 0 (before PIN injection), 2, 3 (before PIN injection) and 5 during each treatment cycle ( (each cycle is 21 days)).
The level of cytokines in serum
PB samples are collected at least on days 0 (before PIN injection), 2, 3 (before PIN injection) and 5 during each treatment cycle ( (each cycle is 21 days)).

Study Arms (1)

Arm: PIN+anti-PD1

EXPERIMENTAL

1. Initial treatment phase: The combined treatment of PIN and anti-PD1 will be administered for 8 cycles; Unless PD or serious intolerable AEs. 2. Maintenance treatment phase: For patients who completed 8 cycles treatment and obtained effective disease control, if residual tumor lesions are still accessible for local injection, combination therapy will be continued. If no injectable lesion, anti-PD1 will be administrated per 3 weeks till 2 years unless PD or serious intolerable AEs. 3. Salvage treatment phase: For patients who experience disease recurrence or progression 16 weeks after ceasing PIN injection, if there are accessible lesions available for PIN injection, combination therapy will be resumed. If specific T cells induced by PIN can be detected in PB when there is no injectable lesion, then the specific T cells are amplified and transfused for salvage therapy.

Biological: PIN +anti-PD1

Interventions

PIN +anti-PD1Biological

1. Initial treatment phase: PIN injection frequency: day0 and day 3, per 3 weeks for 8 cycles; PIN injection dosage: Cycle1: 4e9 or 8e9 viral particles of PIN based on the number of injectable lesions, their longest diameter, and the tumor volume capacity . Cycle 2\~8: 4e9 or 8e9 viral particles of PIN based on the tumor volume's capacity. Anti-PD1: day -3, per 3 weeks for 8 cycles; 2. Maintenance treatment phase: No injection lesion: Anti-PD1: day 1, per 3 weeks till 2 years unless PD or serious intolerable AEs. Have injection lesion: PIN: 4e9 or 8e9 viral particles based on the tumor volume's capacity, per 6 weeks (within first 24 weeks), then per 8 weeks till 2 years unless unavailability of injection lesion, PD or serious intolerable AEs. Anti-PD1: day 1, per 3 weeks till 2 years unless PD or serious intolerable AEs. 3. Salvage treatment phase: Dosage and frequency of administration refer to the initial treatment phase and maintenance treatment phase.

Arm: PIN+anti-PD1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18-75 (inclusive).
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and Estimated life expectancy of more than 3 months.

Sponsors & Collaborators

Changping Laboratory
Othercollaborator
Chinese PLA General Hospital
Otherlead

Study Sites (1)

Biotherapeutic Department of Chinsese PLA Gereral Hospital

Beijing, Beijing Municipality, China

RECRUITING

Weidong Han, Ph.DCONTACT010-66937231 hanwdrsw@sina.com

Study Officials

Weidong Han, Ph.D
Biotherapeutic Department, Chinese PLA General Hospital
PRINCIPAL INVESTIGATOR
Lilin Ye, Ph.D
Department of Tumor Immunology, Changping Laboratory
STUDY DIRECTOR
Zhijun Wang, M.D
Department of Interventional radiology, Chinese PLA General Hospital
STUDY DIRECTOR

Central Study Contacts

Weidong Han, Ph.D

CONTACT

010-66937231 hanwdrsw@sina.com

Yang Liu, M.D

CONTACT

010-66937463

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of Biotherapeutic Department

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 19, 2025

Study Start

March 19, 2025

Actual (reported)

Primary Completion

June 30, 2026

Estimated (date passed)

You may not qualify if:

Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 drug-related Central Nervous System (CNS) toxicity.
Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management.
Any serious underlying medical (eg, pulmonary, renal, hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements.
Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
Received cytotoxic chemicals, monoclonal antibodies, immunotherapy or other intervene within 4 weeks or 5 half-lives before enrollment.
Received radiotherapy within 3 months before enrollment.
Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy.
The presence of uncontrollable serous membrane fluid, such as massive pleural effusion or ascites.
Previous or concurrent cancer within 3 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation.
History of allergy or intolerance to study drug components.
Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.
Being participating any other trials or withdraw within 4 weeks.
+1 more criteria

PIN in Combination With Anti-PD1 in Previously Treated Solid Tumor

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (2)

Study Arms (1)

Arm: PIN+anti-PD1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (2)

Study Arms (1)

Arm: PIN+anti-PD1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations