Advanced TumorPhase 1/2NCT05839106
Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors
A Phase 1/2 study testing PM1032 injection in people with Advanced Tumor, run by Biotheus Inc. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Tumor
- What is being tested?
- PM1032 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 8 Jul 2022to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 16Show fewer
- 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;
- Other conditions considered unsuitable for this study by the investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Shulan (Hang Zhou) Hospital
Hangzhou
Lihua Wu, lihuawu73@163.com
- Recruiting
The first affiliated hospital of nanchang university
Nanchang
Yong Li, liyongcsco@qq.com
- Recruiting
Shanghai Orient Hospital
Shanghai
Ye Guo, pattrickguo@gmail.com
About this study
Official title: A Phase I/IIa Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1032 in Patients With Advanced Solid Tumors
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.
Read the detailed description
PM1032 is a Bispecific Antibody Targeting CLDN18.2 and 4-1BB.
- Conditions
- Advanced Tumor
- Being tested
- PM1032 injection
- Keywords
- CLDN 18.2, 4-1BB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM1032 injectionDrug
Also called PM1032
Subjects will receive PM1032 by intravenous administration.
| Study group | Role | What they receive |
|---|---|---|
| PM1032 monotherapy | Experimental | PM1032 0.3mg/kg-12mg/kg Receives: Drug: PM1032 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity（DLT）
Occurrence of DLT after receiving PM1032 injection
Measured: 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
Measured: Up to 30 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start8 Jul 2022
- Primary completion10 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorStudies of the same condition, open and under way.
- More trials run by Biotheus Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotheus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Guo, Principal investigator, Shanghai Orient Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839106
- Sponsor's protocol ID
- PM1032-AB001M-ST-R
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be published or presented for publications (poster, abstract, articles or papers) or maked any presentations.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1032 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05839106
- Acronym / sponsor ID
- PM1032-AB001M-ST-R
- Conditions
- Advanced Tumor
- Keywords
- CLDN 18.2, 4-1BB
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PM1032 monotherapy | Experimental | Drug: PM1032 injectionPM1032 0.3mg/kg-12mg/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Adequate organ function;
- ECOG score was 0-1;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM1032 injectionAlso: PM1032Subjects will receive PM1032 by intravenous administration. | Drug | PM1032 monotherapy |
Primary outcome
Dose Limited Toxicity（DLT）
Time frame: up to 21 days
Occurrence of DLT after receiving PM1032 injection
Assess the incidence and severity of treatment-related adverse events
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Yes. The data will be published or presented for publications (poster, abstract, articles or papers) or maked any presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Guo principal investigator
Shanghai Orient Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PM1032 injection in people with Advanced Tumor, run by Biotheus Inc. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiying Dong (+86 13867126972, dong.xy@biotheus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity（DLT） (time frame: up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.