Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Tumor
• Interventions: Drug: PM1032 injection

• Registration Number: NCT05839106
• Lead Sponsor: Biotheus Inc.

Brief Summary

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1032 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1032.

Detailed Description

PM1032 is a Bispecific Antibody Targeting CLDN18.2 and 4-1BB.

Study Timeline

• Study Start: 2022-07-08
• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Status Verified: 2023-05
• Study First Posted: 2023-05-03
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-04-10
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily;

• Male or female aged 18 to 75 years;

• Subjects with malignant tumor confirmed by histology or cytology, subjects with advanced malignant solid tumors who have no standard treatment, have failed standard treatment or are not eligible for standard treatment:

  1. Phase I dose escalation stage: gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, etc.;
  2. Phase I dose expansion stage, phase IIa dose expansion stage: gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, other tumors; CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay in central laboratory.

• Adequate organ function;

• ECOG score was 0-1;

• Expected survival≥12 weeks;

Exclusion Criteria

• History of severe allergic, severe allergy to drugs or known allergy to any component of the drug in this study;

• Previous exposure to immune co-stimulatory molecule agonists such as 4-1BB mono/bispecific antibodies, etc;

• Patients who received CLDN18.2-targeted mono/bispecific antibodies or cell therapy;

• Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms were deemed unsuitable for this study by the investigator;

• Current definite interstitial lung disease or non-infectious pneumonitis, except for local radiotherapy;

• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;

• Adverse reactions to previous anti-tumor therapy have not recovered to NCI-CTCAE V5.0 rating≤1;

• 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 or requiring elective surgery during the trial period;
  2. Received live attenuated vaccine within 28 days prior to the study treatment;
  3. Received chemotherapy, radical/extensive radiation, biotherapy, endocrine therapy and other anti-tumor drug therapy within 4 weeks of the first administration;
  4. Received systemic glucocorticoid or other immunosuppressive therapy within 2 weeks before the trial treatment;

• Active bleeding within 3 months of the first administration;

• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;

• Pregnant or lactating women;

• Other conditions considered unsuitable for this study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PM1032 monotherapy	PM1032 injection	PM1032 0.3mg/kg-12mg/kg

Primary Outcome Measures

Name	Time	Method
Dose Limited Toxicity（DLT）	up to 21 days	Occurrence of DLT after receiving PM1032 injection
Assess the incidence and severity of treatment-related adverse events	Up to 30 days after last treatment	The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0

Trial Locations

Locations (3)

Shanghai Orient Hospital; 🇨🇳 Shanghai, China

Shulan (Hang Zhou) Hospital; 🇨🇳 Hangzhou, China

The first affiliated hospital of nanchang university; 🇨🇳 Nanchang, China