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

NCT05839106 | Unknown Phase 1

• 1 other identifier: PM1032-AB001M-ST-R
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Tumor

Keywords

CLDN 18.2; 4-1BB

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity（DLT）

  Occurrence of DLT after receiving PM1032 injection

  up to 21 days

• Assess the incidence and severity of treatment-related adverse events

  The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0

  Up to 30 days after last treatment

Study Arms (1)

PM1032 monotherapy

EXPERIMENTAL

PM1032 0.3mg/kg-12mg/kg

Drug: PM1032 injection

Interventions

PM1032 injection DRUG

Subjects will receive PM1032 by intravenous administration.

Also known as: PM1032

PM1032 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:

• 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:
• Phase I dose escalation stage: gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, etc.;
• 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;

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 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:
• Major organ surgery within 28 days prior to initiation of trial treatment or requiring elective surgery during the trial period;
• Received live attenuated vaccine within 28 days prior to the study treatment;
• Received chemotherapy, radical/extensive radiation, biotherapy, endocrine therapy and other anti-tumor drug therapy within 4 weeks of the first administration;
• 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;

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (3)

Shulan (Hang Zhou) Hospital

Hangzhou, China

RECRUITING

The first affiliated hospital of nanchang university

Nanchang, China

RECRUITING

Shanghai Orient Hospital

Shanghai, China

RECRUITING

Study Officials

• Ye Guo

  Shanghai Orient Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiying Dong

CONTACT

+86 13867126972; dong.xy@biotheus.com

Study Design

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

Model Details: In dose escalation stage, three subjects will be enrolled at the protocol starting dose of PM1032 for 21 Days DLT observation, followed by same dose every 2 weeks (Q2W) until they meet the discontinuation criteria. Dose escalation will proceed to the next dose level according to the 3+3 design. Dose expansion stage of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose escalation stage.

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: July 8, 2022
• Primary Completion: April 10, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-05

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 (3)