A Phase 1/2 interventional study of PM8002 in Malignant Neoplasm, sponsored by Biotheus Inc.. Recruiting at 48 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Biotheus Inc. (part of BioNTech SE) · Phase 1/2, Interventional, and Treatment
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 380 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Biotheus Inc. is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
First submitted before Biotheus Inc. became part of BioNTech SE.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)
Drug: PM8002
IV infusion
Number of participants with DLTs
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.
Time frame: During the first three weeks of treatment with PM8002
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Time frame: Up to 30 days after last treatment
Objective response rate (ORR)
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1). for subjects with no documented disease progression, the deadline is the data of the last examination.
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with PM8002 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM8002.
Time frame: Up to 30 days after last treatment
Plan to share: Yes — The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.
Time frame: After the trial completed
Access criteria: NCI is committed to sharing data in accordance with NIH policy.
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Nov 2025, 56 months after the start.
Of 297 industry-sponsored phase 1/2 interventional studies under Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 84. This study's planned 56 months is close to that.
Counting every sponsor, half of 417 studies reached it within 59 months; a quarter within 36 and three quarters within 84.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pumitamig