A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours

NCT ID: NCT05607563

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2023-12-31

Brief Summary

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009.

PM1009 is a new novel fully human anti-TIGIT x PVRIG bispecific antibody, containing a wildtype IgG1 Fc and has high monovalent affinity to each target, it can binds to both TIGIT and PVRIG overexpressing target cells and binds to TIGIT and PVRIG simultaneously.

Detailed Description

This is a single-arm, open-label, Phase I study contains dose escalation stage and dose expansion stage.

The dose escalation stage will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 10 to 24 patients with advanced tumors.

The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 30 patients with advanced tumors.

Conditions

Advanced Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PM1009 120 mg monotherapy

PM1009 120 mg

Group Type: EXPERIMENTAL

PM1009 injection

Intervention Type: DRUG

Participants receive PM1009 intravenously, every 2 weeks

PM1009 300 mg monotherapy

PM1009 300 mg

Group Type: EXPERIMENTAL

PM1009 injection

Intervention Type: DRUG

Participants receive PM1009 intravenously, every 2 weeks

PM1009 600 mg monotherapy

PM1009 600 mg

Group Type: EXPERIMENTAL

PM1009 injection

Intervention Type: DRUG

Participants receive PM1009 intravenously, every 2 weeks

PM1009 1200 mg monotherapy

PM1009 1200 mg

Group Type: EXPERIMENTAL

PM1009 injection

Intervention Type: DRUG

Participants receive PM1009 intravenously, every 2 weeks

Interventions

PM1009 injection

Participants receive PM1009 intravenously, every 2 weeks

Intervention Type: DRUG

Other Intervention Names

PM1009

Eligibility Criteria

Inclusion Criteria

• Patients participate in the study voluntarily and sign informed consent；
• Male or female, aged 18 to 75 years (including boundary value);
• Subjects with advanced tumor confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment scheme, or standard treatment is not applicable at this stage;
• Having adequate organ function；
• ECOG score is 0-1；
• Expected survival ≥ 12 weeks；
• There is at least one assessable tumor focus.

Exclusion Criteria

• History of severe allergic;
• Those who have received anti-TIGIT or anti-PVRIG therapy in the past;
• Patients who have grade ≥3 immune-mediated adverse event 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;
• Patients ever received the following treatments or drugs prior to the study treatment:

1. Major organ surgery within 28 days prior to initiation of trial treatment;

2. Received live attenuated vaccine within 28 days prior to the study treatment;

3. Received antitumor therapy within 4 weeks prior to the study treatment;

4. Received systemic glucocorticoid within 14 days prior to the study treatment;

• Active infection was present within 14 days before starting study treatment;
• Those with known uncontrolled parenchymal or leptomeningeal metastases;
• 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, except for locally treatable and cured malignancies;
• History of severe cardiovascular and cerebrovascular diseases;
• Patients with uncontrolled tumor-related pain;
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
• History of alcohol, psychotropic substance or drug abuse;
• History of psychiatric disorders or poor compliance;
• History of immunodeficiency, including a positive HIV antibody test;
• Patients with active syphilis infection;
• Patients with active hepatitis B or C;
• Pregnant or lactating women;
• Other conditions considered unsuitable for this study by investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotheus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ye Guo

Role: PRINCIPAL_INVESTIGATOR

Shanghai Orient Hospital

Locations

Shanghai Orient Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuelian Xing

Role: CONTACT

xing.xl@biotheus.com

+86 021 32120207

Other Identifiers

PM1009-A001M-ST-R

Identifier Type: -

Identifier Source: org_study_id