Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

Dose Limited Toxicity (DLT)
Occurrence of DLT after receiving PM1009 injection
up to 21 days
Treatment-related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Up to 30 days after last treatment

Secondary Outcomes (12)

Objective response rate (ORR)
Up to 24 months
Disease control rate (DCR)
Up to 24 months
Progression-free survival (PFS)
Up to 24 months
Overall survival (OS)
Up to 24 months
Anti-drug antibody (ADA)
Up to 30 days after last treatment
+7 more secondary outcomes

Study Arms (1)

PM1015

EXPERIMENTAL

Subjects will be administered PM1015 via intravenously (IV) once in first cycle, then administered PM1015 every 2 weeks (Q2W ) after 3 weeks

Drug: CD73 Antigen

Interventions

CD73 AntigenDrug

subjects will be administered with PM1015 via intravenously (IV) Q2W pemetrexed until progression or accepted other treatment.

Also known as: PM1015 injection

PM1015

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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);

Sponsors & Collaborators

Biotheus Inc.
Industrylead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Lin ShenCONTACTdoctorshenlin@sina.cn

MeSH Terms

Interventions

5'-Nucleotidase

Intervention Hierarchy (Ancestors)

NucleotidasesPhosphoric Monoester HydrolasesEsterasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

Lin Shen, PhD
Peking University Cancer Hospital & Institute
PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhishuo Cheng

CONTACT

+86 199 1072 4988 cheng.zs@biotheus.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 18, 2023

First Posted

July 18, 2023

Study Start

May 10, 2022

Actual (reported)

Primary Completion

September 30, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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;
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;
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:
+12 more criteria

A Study of PM1015 in Patients With Advanced Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Study Arms (1)

PM1015

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Study Arms (1)

PM1015

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations