Advanced TumorsPhase 1/2NCT05867771
A Study of PM1022 in Patients With Advanced Tumors
A Phase 1/2 study testing PM1022 in people with Advanced Tumors, run by Biotheus Inc. at 2 sites in China.
Trial summary
This study incluces a phase I study to evaluate the tolerance, safety, pharmacokinetic characteristics and preliminary efficacy of PM1022 in patients with advanced tumors and a phase IIa study to investigate the efficacy of PM1022 in patients with advanced tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Tumors
- What is being tested?
- PM1022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 11 Apr 2022to 10 Apr 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; willing to follow and able to complete all test procedures;
- No gender limit, aged 18 to 75 years (boundary values included);
- Subjects with malignant tumor confirmed by histology or cytology;
- Adequate organ function;
- Eastern Cooperative Oncology Group score was 0-1;
- Expected survival >=12 weeks;
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- According to RECIST V1.1, there are at least one evaluable or measurable tumor lesion;
- All subjects should undergo biopsy of tumor lesions during the screening; if biopsy is not possible, formalin-fixed-paraffin-embedded (FFPE)-processed tumor samples closest to the start of study treatment should be provided for biomarker analysis;
- Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 5 months from the date of signing the informed consent form to the end of the last medication;
- Male subjects are willing to remain abstinent from sex or use medically approved highly effective contraception from the time of signing the informed consent to 5 months after the end of the last medication, and do not donate sperm during this period.
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 costimulatory molecule agonists or immune checkpoint inhibitors of patients in phase I;
- Patients who have grade >=3 immune-mediated adverse event (AE) 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;
- Received the following treatments or medications before starting treatment:
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- Underwent major organ surgery (excluding needle biopsy) within 28 days before starting study treatment, or required elective surgery during the trial;
- Live attenuated vaccine was administered within 28 days before the study began;
- Received anti-tumor therapy within 4 weeks before the first dose;
- Received systemic glucocorticoids within 14 days prior to study initiation;
- Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms were deemed unsuitable for inclusion by the investigator;
- 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;
- History of severe cardiovascular and cerebrovascular diseases;
- Patients with uncontrolled tumor-related pain;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- Unexplained fever >38.5°C during the screening or before the initiation of study treatment (fever caused by tumor can be included according to the investigator);
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- History of alcohol, psychotropic substance or drug abuse;
- History of psychiatric disorders or poor compliance;
- History of immunodeficiency, including a positive HIV antibody test;
- Patients with active syphilis infection;
- Patients with active hepatitis B or C;
- According to the investigator, the underlying condition of the patient may increase the risk of receiving the investigational drug, or cause confusion for the interpretation of the toxic reaction and AE.
- Pregnant or lactating patients;
- Other conditions considered unsuitable for this study by investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Yan Zhang
Jinan, Shandong
Yan Zhang, +86 13853110681, zhangyan0681@163.com
Yan Zhang
- Recruiting
Ye Guo
Shanghai
Ye Guo, +8613501678472, Pattrickguo@gmail.com
Ye Guo
About this study
Official title: A Phase I/IIa Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1022 in Patients With Advanced Tumors
This study incluces a phase I study to evaluate the tolerance, safety, pharmacokinetic characteristics and preliminary efficacy of PM1022 in patients with advanced tumors and a phase IIa study to investigate the efficacy of PM1022 in patients with advanced tumors.
Read the detailed description
PM1022 is a recombinant humanized anti-PDL1 and anti-TIGIT bispecific antibody. This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of PM1022 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.
- Conditions
- Advanced Tumors
- Being tested
- PM1022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM1022Drug
PM1022 Injection
| Study group | Role | What they receive |
|---|---|---|
| PM1022 | Experimental | PM1022 Injection Receives: Drug: PM1022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
To evaluate the safety and tolerability of PM1022 in treatment of advanced tumors.
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 posted22 May 2023
- Study start11 Apr 2022
- Primary completion10 Apr 2024 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorsStudies 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
- 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 East Hospital (South Campus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867771
- Sponsor's protocol ID
- PM1022-AB001M-ST-R
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 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 PM1022 in Patients With Advanced Tumors
- ClinicalTrials.gov ID
- NCT05867771
- Acronym / sponsor ID
- PM1022-AB001M-ST-R
- Conditions
- Advanced Tumors
- 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
- 11 Apr 2022 (actual)
- Primary completion
- 10 Apr 2024 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 22 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.
This study incluces a phase I study to evaluate the tolerance, safety, pharmacokinetic characteristics and preliminary efficacy of PM1022 in patients with advanced tumors and a phase IIa study to investigate the efficacy of PM1022 in patients with advanced tumors.
Detailed description
PM1022 is a recombinant humanized anti-PDL1 and anti-TIGIT bispecific antibody. This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of PM1022 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM1022 | Experimental | Drug: PM1022PM1022 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
- No gender limit, aged 18 to 75 years (boundary values included);
- Subjects with malignant tumor confirmed by histology or cytology;
- Adequate organ function;
- Eastern Cooperative Oncology Group score was 0-1;
Key exclusion criteria (26 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 costimulatory molecule agonists or immune checkpoint inhibitors of patients in phase I;
- Patients who have grade >=3 immune-mediated adverse event (AE) 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;
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 |
|---|---|---|
| PM1022PM1022 Injection | Drug | PM1022 |
Primary outcome
Adverse events
Time frame: Up to 30 days after last treatment
To evaluate the safety and tolerability of PM1022 in treatment of advanced tumors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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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 East Hospital (South Campus)
2 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 PM1022 in people with Advanced Tumors, run by Biotheus Inc. at 2 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 10 inclusion and 26 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 22 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 2 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 Ye Guo (+86 13501678472, Pattrickguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to 30 days after last treatment). 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 22 May 2023.