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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Advanced Tumor

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PM1032 monotherapy

PM1032 0.3mg/kg-12mg/kg

Group Type EXPERIMENTAL

PM1032 injection

Intervention Type DRUG

Subjects will receive PM1032 by intravenous administration.

Interventions

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PM1032 injection

Subjects will receive PM1032 by intravenous administration.

Intervention Type DRUG

Other Intervention Names

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PM1032

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No