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

NCT05607563 | Unknown Phase 1

• 1 other identifier: PM1009-A001M-ST-R
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Tumor

Keywords

PM1009; TIGIT; PVRIG

Outcome Measures

Primary Outcomes (1)

• Dose Limited Toxicity（DLT）

  Occurrence of DLT after receiving PM1009 injection

  up to 21 days

Secondary Outcomes (16)

• Recommended Phase II Dose (RP2D)

  Up to 30 days after last treatment

• Maximum observed concentration (Cmax)

  Up to 30 days after last treatment

• Time to Cmax (Tmax)

  Up to 30 days after last treatment

• Minimum observed concentration (Cmin)

  Up to 30 days after last treatment

• Trough concentrations (Ctrough)

  Up to 30 days after last treatment

Other Outcomes (1)

• T-lymphocyte phenotypes

  Up to six cycles (each cycle is 2 weeks)

Study Arms (4)

PM1009 120 mg monotherapy

EXPERIMENTAL

PM1009 120 mg

Drug: PM1009 injection

PM1009 300 mg monotherapy

EXPERIMENTAL

PM1009 300 mg

Drug: PM1009 injection

PM1009 600 mg monotherapy

EXPERIMENTAL

PM1009 600 mg

Drug: PM1009 injection

PM1009 1200 mg monotherapy

EXPERIMENTAL

PM1009 1200 mg

Drug: PM1009 injection

Interventions

PM1009 injection DRUG

Participants receive PM1009 intravenously, every 2 weeks

Also known as: PM1009

PM1009 120 mg monotherapy; PM1009 1200 mg monotherapy; PM1009 300 mg monotherapy; PM1009 600 mg monotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Major organ surgery within 28 days prior to initiation of trial treatment;
• Received live attenuated vaccine within 28 days prior to the study treatment;
• Received antitumor therapy within 4 weeks prior to the study treatment;
• 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;

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (1)

Shanghai Orient Hospital

Shanghai, China

RECRUITING

Study Officials

• Ye Guo

  Shanghai Orient Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuelian Xing

CONTACT

+86 021 32120207; xing.xl@biotheus.com

Study Design

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

Model Details: Patients sequentially receive PM1009 120 mg, 300 mg, 600 mg, 1200 mg, intravenously, Q2W

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 7, 2022
• Study Start: November 21, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: after the trial completed
• Access Criteria: NCI is committed to sharing data in accordance with NIH policy.

Locations

CN (1)