A Study of PM1022 in Patients With Advanced Tumors

NCT05867771 | Unknown Phase 1

• 1 other identifier: PM1022-AB001M-ST-R
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

This study incluces a phase I study to evaluate the tolerance, safety, pharmacokinetic characteristics and preliminary efficacy of PM1022 in patients with advanced tumors and a phase IIa study to investigate the efficacy of PM1022 in patients with advanced tumors.

Conditions

Advanced Tumors

Outcome Measures

Primary Outcomes (1)

• Adverse events

  To evaluate the safety and tolerability of PM1022 in treatment of advanced tumors.

  Up to 30 days after last treatment

Study Arms (1)

PM1022

EXPERIMENTAL

PM1022 Injection

Drug: PM1022

Interventions

PM1022 DRUG

PM1022 Injection

PM1022

Eligibility Criteria

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

You may qualify if:

• Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
• No gender limit, aged 18 to 75 years (boundary values included);
• Subjects with malignant tumor confirmed by histology or cytology;
• Adequate organ function;
• Eastern Cooperative Oncology Group score was 0-1;
• Expected survival \>=12 weeks;
• According to RECIST V1.1, there are at least one evaluable or measurable tumor lesion;
• All subjects should undergo biopsy of tumor lesions during the screening; if biopsy is not possible, formalin-fixed-paraffin-embedded (FFPE)-processed tumor samples closest to the start of study treatment should be provided for biomarker analysis;
• Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 5 months from the date of signing the informed consent form to the end of the last medication;
• Male subjects are willing to remain abstinent from sex or use medically approved highly effective contraception from the time of signing the informed consent to 5 months after the end of the last medication, and do not donate sperm during this period.

You may not qualify if:

• History of severe allergic, severe allergy to drugs or known allergy to any component of the drug in this study;
• Previous exposure to immune costimulatory molecule agonists or immune checkpoint inhibitors of patients in phase I;
• Patients who have grade \>=3 immune-mediated adverse event (AE) that associated with a prior immunotherapy;
• Adverse reactions to previous antitumor therapy have not recovered to NCI-CTCAE V5.0 rating \<= 1;
• Current definite interstitial lung disease or non-infectious pneumonitis, except for local radiotherapy;
• Received the following treatments or medications before starting treatment:
• Underwent major organ surgery (excluding needle biopsy) within 28 days before starting study treatment, or required elective surgery during the trial;
• Live attenuated vaccine was administered within 28 days before the study began;
• Received anti-tumor therapy within 4 weeks before the first dose;
• Received systemic glucocorticoids within 14 days prior to study initiation;
• Patients with active autoimmune disease or a history of autoimmune disease with potential for relapse;
• Patients with other active malignancies within 5 years prior to initiation of study treatment;
• History of severe cardiovascular and cerebrovascular diseases;
• Patients with uncontrolled tumor-related pain;
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (2)

Yan Zhang

Jinan, Shandong, China

RECRUITING

Ye Guo

Shanghai, China

RECRUITING

Study Officials

• Ye Guo

  Shanghai East Hospital (South Campus)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Guo

CONTACT

+86 13501678472; Pattrickguo@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 22, 2023
• Study Start: April 11, 2022
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2025
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)