Advanced TumorPhase 1NCT05607563
A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours
A Phase 1 study testing PM1009 injection in people with Advanced Tumor, run by Biotheus Inc. at 1 site in China.
Trial summary
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009. 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?
- PM1009 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2022to Dec 2023
- Phase
- Phase 1
- 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
- Patients participate in the study voluntarily and sign informed consent；
- Male or female, aged 18 to 75 years (including boundary value);
- Subjects with advanced tumor confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment scheme, or standard treatment is not applicable at this stage;
- Having adequate organ function；
- ECOG score is 0-1；
- Expected survival ≥ 12 weeks；
- There is at least one assessable tumor focus.
Who cannot join
- History of severe allergic;
- Those who have received anti-TIGIT or anti-PVRIG therapy in the past;
- Patients who have grade ≥3 immune-mediated adverse event 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;
- Patients ever received the following treatments or drugs prior to the study treatment:
Show all 25Show fewer
- Major organ surgery within 28 days prior to initiation of trial treatment;
- Received live attenuated vaccine within 28 days prior to the study treatment;
- Received antitumor therapy within 4 weeks prior to the study treatment;
- Received systemic glucocorticoid within 14 days prior to the study treatment;
- Active infection was present within 14 days before starting study treatment;
- Those with known uncontrolled parenchymal or leptomeningeal metastases;
- 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, except for locally treatable and cured malignancies;
- History of severe cardiovascular and cerebrovascular diseases;
- Patients with uncontrolled tumor-related pain;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- 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;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumors
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009.
PM1009 is a new novel fully human anti-TIGIT x PVRIG bispecific antibody, containing a wildtype IgG1 Fc and has high monovalent affinity to each target, it can binds to both TIGIT and PVRIG overexpressing target cells and binds to TIGIT and PVRIG simultaneously.
Read the detailed description
This is a single-arm, open-label, Phase I study contains dose escalation stage and dose expansion stage.
The dose escalation stage will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 10 to 24 patients with advanced tumors.
The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 30 patients with advanced tumors.
- Conditions
- Advanced Tumor
- Being tested
- PM1009 injection
- Keywords
- PM1009, TIGIT, PVRIG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM1009 injectionDrug
Also called PM1009
Participants receive PM1009 intravenously, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| PM1009 120 mg monotherapy | Experimental | PM1009 120 mg Receives: Drug: PM1009 injection |
| PM1009 300 mg monotherapy | Experimental | PM1009 300 mg Receives: Drug: PM1009 injection |
| PM1009 600 mg monotherapy | Experimental | PM1009 600 mg Receives: Drug: PM1009 injection |
| PM1009 1200 mg monotherapy | Experimental | PM1009 1200 mg Receives: Drug: PM1009 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 PM1009 injection
Measured: up to 21 days
Secondary outcomes (16)
Recommended Phase II Dose (RP2D)
To determine the RP2D of PM1009 injection
Measured: Up to 30 days after last treatment
Maximum observed concentration (Cmax)
To evaluate the Cmax of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Time to Cmax (Tmax)
To evaluate the Tmax of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Minimum observed concentration (Cmin)
To evaluate the Cmin of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Trough concentrations (Ctrough)
To evaluate the Ctrough of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Area under the concentration-time curve (AUC0-last)
To evaluate the AUC0-last of PM1009 monotherapy
Measured: Up to 30 days after last treatment
AUC to the end of the dosing period(AUC0-tau)
To evaluate the AUC0-tau of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Apparent terminal elimination half-life (t1/2)
To evaluate the t1/2 of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Accumulation ratio calculated based on Cmax (Rac_Cmax)
To evaluate the Rac_Cmax of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Accumulation ratio calculated based on AUC (Rac_AUC)
To evaluate the Rac_AUC of PM1009 monotherapy
Measured: Up to 30 days after last treatment
Objective response rate (ORR)
Defined as the number of patients with best overall response of confirmed CR or PR per RECIST 1.1 divided by the patients with at least one tumour imaging evaluation
Measured: Up to 24 months
Disease control rate (DCR)
Defined as the percentage of patients who have achieved CR, PR, Non-CR/Non-PD, or SD in the study.
Measured: Up to 24 months
Progression-free survival (PFS)
Defined as the time from the date of first dose of study drug to the first observation of documented disease progression per RECIST 1.1 as determined by the Investigators or death due to any cause, whichever occurs first.
Measured: Up to 24 months
Overall survival (OS)
Defined as the time from the date of first dose of study drug to the date of documented death due to any cause.
Measured: Up to 24 months
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM1009 injection
Measured: Up to 30 days after last treatment
Adverse Events（AE）and Serious Adverse Events（SAE）
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 posted7 Nov 2022
- Study start21 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients sequentially receive PM1009 120 mg, 300 mg, 600 mg, 1200 mg, intravenously, Q2W
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT05607563
- Sponsor's protocol ID
- PM1009-A001M-ST-R
- Status last verified
- Nov 2022
- First submitted
- 19 Oct 2022
- Last updated
- 8 Feb 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumors
- ClinicalTrials.gov ID
- NCT05607563
- Acronym / sponsor ID
- PM1009-A001M-ST-R
- Conditions
- Advanced Tumor
- Keywords
- PM1009, TIGIT, PVRIG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Nov 2022 (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 PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009.
PM1009 is a new novel fully human anti-TIGIT x PVRIG bispecific antibody, containing a wildtype IgG1 Fc and has high monovalent affinity to each target, it can binds to both TIGIT and PVRIG overexpressing target cells and binds to TIGIT and PVRIG simultaneously.
Detailed description
This is a single-arm, open-label, Phase I study contains dose escalation stage and dose expansion stage.
The dose escalation stage will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 10 to 24 patients with advanced tumors.
The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 30 patients with advanced tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients sequentially receive PM1009 120 mg, 300 mg, 600 mg, 1200 mg, intravenously, Q2W
| Arm | Type | Receives |
|---|---|---|
| PM1009 120 mg monotherapy | Experimental | Drug: PM1009 injectionPM1009 120 mg |
| PM1009 300 mg monotherapy | Experimental | Drug: PM1009 injectionPM1009 300 mg |
| PM1009 600 mg monotherapy | Experimental | Drug: PM1009 injectionPM1009 600 mg |
| PM1009 1200 mg monotherapy | Experimental | Drug: PM1009 injectionPM1009 1200 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients participate in the study voluntarily and sign informed consent；
- Male or female, aged 18 to 75 years (including boundary value);
- Subjects with advanced tumor confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment scheme, or standard treatment is not applicable at this stage;
- Having adequate organ function；
- ECOG score is 0-1；
Key exclusion criteria (25 listed)
- History of severe allergic;
- Those who have received anti-TIGIT or anti-PVRIG therapy in the past;
- Patients who have grade ≥3 immune-mediated adverse event 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 |
|---|---|---|
| PM1009 injectionAlso: PM1009Participants receive PM1009 intravenously, every 2 weeks | Drug | PM1009 120 mg monotherapy, PM1009 1200 mg monotherapy, PM1009 300 mg monotherapy, PM1009 600 mg monotherapy |
Primary outcome
Dose Limited Toxicity（DLT）
Time frame: up to 21 days
Occurrence of DLT after receiving PM1009 injection
16 secondary outcomes
Recommended Phase II Dose (RP2D)
Time frame: Up to 30 days after last treatment
Maximum observed concentration (Cmax)
Time frame: Up to 30 days after last treatment
Time to Cmax (Tmax)
Time frame: Up to 30 days after last treatment
Minimum observed concentration (Cmin)
Time frame: Up to 30 days after last treatment
Trough concentrations (Ctrough)
Time frame: Up to 30 days after last treatment
Area under the concentration-time curve (AUC0-last)
Time frame: Up to 30 days after last treatment
AUC to the end of the dosing period(AUC0-tau)
Time frame: Up to 30 days after last treatment
Apparent terminal elimination half-life (t1/2)
Time frame: Up to 30 days after last treatment
Accumulation ratio calculated based on Cmax (Rac_Cmax)
Time frame: Up to 30 days after last treatment
Accumulation ratio calculated based on AUC (Rac_AUC)
Time frame: Up to 30 days after last treatment
Objective response rate (ORR)
Time frame: Up to 24 months
Disease control rate (DCR)
Time frame: Up to 24 months
Progression-free survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Anti-drug antibody (ADA)
Time frame: Up to 30 days after last treatment
Adverse Events（AE）and Serious Adverse Events（SAE）
Time frame: Up to 30 days after last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PM1009 injection in people with Advanced Tumor, run by Biotheus Inc. at 1 site 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 7 inclusion and 25 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Xuelian Xing (+86 021 32120207, xing.xl@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). 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 8 Feb 2023.