Advanced Solid TumorPhase 1NCT05950815
A Study of PM1015 in Patients With Advanced Solid Tumors
A Phase 1 study testing CD73 Antigen in people with Advanced Solid Tumor, run by Biotheus Inc. at 1 site in China.
Trial summary
PM1015 is a specific antibody targeting CD73. This is a phase I study to evaluate the efficacy and safety of PM1015 in patients with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CD73 Antigen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2022to 30 Sep 2024
- 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
- Volunteer to participate in clinical trials; Fully understand the test and voluntarily sign the informed consent; Willing to follow and able to complete all test procedures;
- No gender limit, aged between 18 and 75 years (including boundary values);
- Subjects with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no standard treatment options, or are not currently eligible for standard treatment;
- Adequate organ function, as defined below:
- Blood system (in the absence of blood transfusion, granulocyte colony stimulating factor, or other medical support within 14 days prior to initiation of trial therapy) : neutrophil count (ANC) >= 1.5 x 10^9 /L; Platelet count (PLT) >= 100 x 10^9 /L; Hemoglobin (Hb) >= 90 g/L;
- Liver function: total bilirubin (TBIL) <= 1.5 x upper limit of normal (ULN), subjects with liver metastasis or liver cancer <= 2 x ULN; Subjects with Gilbert disease should be <= 3 x ULN; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 2.5 x ULN (subjects with liver metastasis or liver cancer: <= 3 x ULN);
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- Renal function: serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min (Cockcroft-Gault formula: [(140 - age) x body weight (kg) x 0.85 (for females only)] / [72 x creatinine (mg/dL)]; (Creatinine unit conversion: 1 mg/dL = 88.4 μmol/L); Qualitative urine protein <= 1+; If the qualitative urine protein >= 2+, 24h urine protein quantitative examination is required; if the quantitative urine protein < 1g, it is acceptable;
- Coagulation function: International standardized ratio (INR) and activated partial thrombin time (APTT) should be less than 1.5 x ULN; Subjects with liver metastasis or liver cancer should be <= 2 x ULN;
- Physical status: The Eastern Cooperative Oncology Group (ECOG) physical status score was 0-1;
- Expected survival >= 12 weeks;
- Dose escalation test: According to RECIST version 1.1, there is at least one evaluable tumor lesion; Initial dose extension test: At least one measurable tumor lesion according to RECIST version 1.1; (Tumor lesions located in the area of previous radiotherapy or other local regional treatment sites are generally not considered as measurable lesions, unless the lesions show definite progression or persist 3 months after radiotherapy; Not accept only bone metastases or only central nervous system metastases as measurable lesions);
- All subjects should undergo a fresh tumor lesion biopsy during the screening period (No bone biopsy; Biopsy is also not acceptable in subjects with a single target lesion for biopsy); If biopsy is not possible, subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples from the nearest (up to 24 months) to the start of the trial for biomarker analysis; If the subject is unable to provide specimens that meet the above requirements due to special reasons, the subject may participate in screening with the consent of the sponsor's medical monitor;
- A fertile female subject has a negative serum-pregnancy result within 7 days prior to the start of the trial treatment and is willing to abstain from sex or use a medically approved highly effective contraceptive method (e.g. IUD, condom) from the date of signing the informed consent to 6 months after the end of the final medication;
- Male subjects are willing to abstain from sex or use a medically approved highly effective contraceptive method for 6 months from the date of signing the informed consent, and do not donate sperm during this period.
Who cannot join
- History of severe allergic disease, allergy to serious drugs (including unmarketed test drugs) or known allergy to any component of the test drug;
- Previous treatment with adenosine inhibitors (such as anti-CD73, anti-CD39, or anti-A2aR);
- Received an unmarketed investigational drug or treatment within 4 weeks prior to initiation of the trial treatment, or is still within the drug's 5 half-lives (if known), whichever is longer;
- The adverse reactions of previous antitumor therapy have not recovered to the NCI-CTCAE V5.0 rating <= grade 1 (except for toxicities without safety risks as determined by the researchers, such as hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.);
- Received the following treatments or drugs before starting the trial therapy:
- Major organ surgery (excluding needle biopsy) or major trauma or invasive dental procedures within 4 weeks before the initiation of trial treatment, or the need for elective surgery during the trial;
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- Within 4 weeks prior to initiation of trial therapy, received chemotherapy, radical/extensive radiotherapy, endocrine therapy, biological therapy (such as tumor vaccine, cytokine), immune checkpoint agonists (such as 4-1BB agonists, OX40 agonists) or immune checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-LAG-3) and other anti-tumor therapy; Received nitrosourea and mitomycin C within 6 weeks prior to initiation of treatment; Received oral fluorouracil, small-molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications within 2 weeks before the start of the experimental treatment; Received palliative radiotherapy for vital organs (such as liver, brain, lung, etc.) within 7 days prior to the start of trial therapy;
- Received systemic glucocorticoid (prednisone >10 mg/ day or equivalent dose of the same drug) or other immunosuppressant therapy within 14 days prior to the initial use of the test drug; Except in the following cases: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; Short-term use of glucocorticoids for preventive treatment (e.g. to prevent hypersensitivity to contrast media);
- Have received live attenuated vaccine within 4 weeks before the first use of the trial drug;
- History of immune deficiency, including HIV antibody positive test;
- Syphilis antibody positive;
- HBsAg or HBcAb positive, HBV-DNA > 500 IU/mL or lower limit of detection in test center (only when lower limit of detection in test center is higher than 500 IU/mL); HCV antibody positive and HCV-RNA higher than the lower limit of test center detection; 9. Subjects with brain parenchymal metastasis or meningeal metastasis with clinical symptoms were judged by the researchers to be unsuitable for inclusion;
- Active infection;
- Subjects with active or previous autoimmune diseases with potential recurrence (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except clinically stable autoimmune thyroid disease and type I diabetes;
- Currently with uncontrollable pleural, pericardial and abdominal effusion;
- A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree Ⅱ-Ⅲ atrioventricular block;
- The mean QT interval (QTcF) corrected by Fridericia was >450 ms for male and > 470 ms for female;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before trial administration began;
- New York Heart Association Cardiac Function Grade >= II, or left ventricular ejection fraction (LVEF) < 50%;
- Clinically uncontrolled hypertension (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >=100 mmHg);
- The presence of any factors that increase the risk of prolonged QTc or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, or the use of any concomitant drugs known to prolong the QT interval;
- Previous history of allogeneic organ transplantation or allohematopoietic stem cell transplantation;
- A known history of alcohol abuse, psychotropic substance abuse or drug use;
- Subjects with mental disorders or poor compliance;
- Pregnant or lactating subjects;
- According to the investigator's judgment, the basic condition of the subject may increase the risk of receiving the trial drug treatment, or cause confusion in the interpretation of toxic reactions and AEs;
- Other circumstances in which the investigator did not consider participation in the trial appropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Lin Shen, doctorshenlin@sina.cn
About this study
Official title: A Phase I Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1015 in Patients With Advanced Solid Tumors
PM1015 is a specific antibody targeting CD73. This is a phase I study to evaluate the efficacy and safety of PM1015 in patients with advanced solid tumor.
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 13 to 24 patients with advanced tumors. The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 24 patients with advanced tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- CD73 Antigen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD73 AntigenDrug
Also called PM1015 injection
subjects will be administered with PM1015 via intravenously (IV) Q2W pemetrexed until progression or accepted other treatment.
| Study group | Role | What they receive |
|---|---|---|
| PM1015 | Experimental | Subjects will be administered PM1015 via intravenously (IV) once in first cycle, then administered PM1015 every 2 weeks (Q2W ) after 3 weeks Receives: Drug: CD73 Antigen |
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
Treatment-related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Measured: Up to 30 days after last treatment
Secondary outcomes (12)
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)
PM1015 anti-drug antibody
Measured: Up to 30 days after last treatment
Recommended Phase II Dose (RP2D)
To determine the RP2D of PM1015 injection
Measured: Up to 30 days after last treatment
Maximum observed concentration (Cmax)
To evaluate the Cmax of PM1015 monotherapy
Measured: Up to 30 days after last treatment
Time to Cmax (Tmax)
To evaluate the Tmax of PM1015 monotherapy
Measured: Up to 30 days after last treatment
Minimum observed concentration (Cmin)
To evaluate the Cmin of PM1015 monotherapy
Measured: Up to 30 days after last treatment
Trough concentrations (Ctrough)
To evaluate the Ctrough of PM1015 monotherapy
Measured: Up to 30 days after last treatment
Area under the concentration-time curve (AUC0-last)
To evaluate the AUC0-tau of PM1015 monotherapy
Measured: Up to 30 days after last treatment
Apparent terminal elimination half-life (t1/2)
To evaluate the t1/2 of PM1015 monotherapy
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 posted18 Jul 2023
- Study start10 May 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotheus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950815
- Sponsor's protocol ID
- PM1015-A001M-ST-R
- Status last verified
- Jul 2023
- First submitted
- 18 May 2023
- Last updated
- 18 Jul 2023
- Results posted
- 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 any presentations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1015 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05950815
- Acronym / sponsor ID
- PM1015-A001M-ST-R
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Jul 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.
PM1015 is a specific antibody targeting CD73. This is a phase I study to evaluate the efficacy and safety of PM1015 in patients with advanced solid tumor.
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 13 to 24 patients with advanced tumors. The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 24 patients with advanced tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM1015 | Experimental | Drug: CD73 AntigenSubjects will be administered PM1015 via intravenously (IV) once in first cycle, then administered PM1015 every 2 weeks (Q2W ) after 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Volunteer to participate in clinical trials; Fully understand the test and voluntarily sign the informed consent; Willing to follow and able to complete all test procedures;
- No gender limit, aged between 18 and 75 years (including boundary values);
- Subjects with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no standard treatment options, or are not currently eligible for standard treatment;
- Adequate organ function, as defined below:
- Physical status: The Eastern Cooperative Oncology Group (ECOG) physical status score was 0-1;
Key exclusion criteria (28 listed)
- History of severe allergic disease, allergy to serious drugs (including unmarketed test drugs) or known allergy to any component of the test drug;
- Previous treatment with adenosine inhibitors (such as anti-CD73, anti-CD39, or anti-A2aR);
- Received an unmarketed investigational drug or treatment within 4 weeks prior to initiation of the trial treatment, or is still within the drug's 5 half-lives (if known), whichever is longer;
- The adverse reactions of previous antitumor therapy have not recovered to the NCI-CTCAE V5.0 rating <= grade 1 (except for toxicities without safety risks as determined by the researchers, such as hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.);
- Received the following treatments or drugs before starting the trial therapy:
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 |
|---|---|---|
| CD73 AntigenAlso: PM1015 injectionsubjects will be administered with PM1015 via intravenously (IV) Q2W pemetrexed until progression or accepted other treatment. | Drug | PM1015 |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: up to 21 days
Occurrence of DLT after receiving PM1009 injection
Treatment-related adverse events (TRAEs)
Time frame: Up to 30 days after last treatment
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
12 secondary outcomes
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
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
Apparent terminal elimination half-life (t1/2)
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 18 Jul 2023.
- Individual participant dataSharing planned: Yes. The data will be published or presented for publications (poster, abstract, articles or papers) or 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.
Lin Shen, PhD principal investigator
Peking University Cancer Hospital & Institute
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 CD73 Antigen in people with Advanced Solid 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 14 inclusion and 28 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 18 Jul 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 Zhishuo Cheng (+86 199 1072 4988, cheng.zs@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 18 Jul 2023.