A Clinical Study of PA5 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Peg-Bio Biopharm Co., Ltd.
About this trial
The goal of this clinical trial is to learn if PA5 is safe and works to treat advanced solid tumors in adults. It will also learn about the tolerability and PK/PD profile of PA5. The main questions it aims to answer are:
* Is intravenous infusion of PA5 monotherapy safe and tolerable for patients with advanced/metastatic solid tumors? * What is the maximum tolerated dose (MTD) and recommended dose for Phase II clinical trials (RP2D) of PA5 monotherapy?
In the escalation phase, participants will receive PA5 via intravenous infusion on Day 1 of Cycle 1 (28-day cycle). If no dose-limiting toxicity (DLT) occurs, treatment continues from Cycle 2 onward with adjusted frequency (every 2-4 weeks).
In the expansion phase, participants will receive PA5 with the frequency determined based on the results of the escalation phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, male or female.
Patients with histologically or cytologically confirmed advanced/metastatic solid tumors that are unresectable, stage III or IV, have failed standard therapy, are intolerant to standard therapy, have no standard therapy available, or unable to benefit from standard therapy.
At least one evaluable lesion (dose escalation phase) or at least one measurable lesion (dose expansion phase) according to RECIST v1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Participants who have received chemotherapy, targeted therapy, anti-tumor Chinese herbal medicine, or palliative care within 2 weeks or 5 half-lives (whichever is longer) prior to the initiation of study treatment; or major surgery, radiotherapy, immunotherapy, or participation in another clinical trial within 4 weeks or 5 half-lives (whichever is longer); or live virus vaccination within 4 weeks or inactivated vaccination within 2 weeks prior to initiation of study treatment.
Presence of pleural effusion or ascites requiring clinical intervention (except for participants not requiring drainage or with stable effusion for ≥2 weeks after drainage); presence of pericardial effusion (except for minimal, stable effusion for ≥2 weeks).
Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 2 per NCI-CTCAE v5.0 (excluding toxicities judged by the investigator to pose no safety risk, such as alopecia).
Participants taking drugs known to prolong the QTc interval or with risk factors for QTc interval prolongation.
Trial design
Design model
Single group
Treatments tested in this trial
PA5
Biological/VaccineAdministration is performed via intravenous infusion. A single dose is administered in the first cycle; the second cycle is tentatively scheduled for once every two weeks, with 4 weeks defined as one treatment cycle. Dosing continues until the occurrence of disease progression, intolerable toxicity, death, a decision made by the investigator, or voluntary withdrawal of the participant.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: PA5Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose limiting toxicity (DLT)
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
The maximum tolerated dose (MTD)
Time frame
At the end of Cycle 1 (each cycle is 28 days)3
Adverse Events (AEs)
including the incidence of overall and categorized AEs, severity (graded according to NCI CTCAE v5.0), seriousness, relationship to PA5 treatment, duration, and outcome.
Time frame
From Day 1 of Cycle 1 to Day 28 of Cycle 7 (each cycle is 28 days) or to the end of the treatment (whichever occurs earlier)4
Recommended phase 2 dose (RP2D) of PA5
Determine RP2D based on the efficacy and safety of PA5 during the dose escalation and expansion phases
Time frame
On Day 28 of Cycle 7 (each cycle is 28 days) or at the end of the treatment (whichever occurs earlier)Sponsors and contacts
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Source ClinicalTrials.gov