Health TrialsbyHealthPanel

PM8002 in the Treatment of Patients With Advanced Solid Tumors

ConditionMalignant Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiotheus Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;

Male or female aged 18 to 75 years;

Patients with malignant tumor confirmed by histology or cytology;

The toxicity of previous anti-tumor therapy has not been alleviated；

Disqualifiers

History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;

Evidence of major coagulopathy or other obvious risk of bleeding;

Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;

Patients with uncontrolled brain metastases should be excluded from this clinical trial;

Trial design

Design model

Sequential

Treatments tested in this trial

  • PM8002

    Drug

    IV infusion

Treatment groups

380 Participants
are divided into 1 treatment group
Group A: PM8002Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biotheus Inc.

Lead sponsor

Source ClinicalTrials.gov
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