Advanced Solid TumorsPhase 1NCT07702162
A Clinical Study of PA5 in Patients With Advanced Solid Tumors
A Phase 1 study testing PA5 in people with Advanced Solid Tumors and Cancer, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Cancer
- What is being tested?
- PA5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesChina
- Study dates
- 14 Nov 2025to 4 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Expected life expectancy of at least 12 weeks.
- Brain metastases must be well-controlled and without epileptic symptoms.
- Participants must have adequate organ and bone marrow function.
Who cannot join
- 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.
- Clinically significant active bacterial, fungal, or viral infection.
- Other malignancies besides the indication under study, either currently or in the past, except for: cured cervical carcinoma in situ (stage IB or lower), non-invasive basal cell or squamous cell skin cancer, malignant melanoma with complete remission (CR) >10 years, or other malignancies with CR >5 years.
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- Pregnant or breastfeeding women.
- History of allergy to polyethylene glycol compounds.
- Prior treatment with ADI-PEG20 or other drugs of the same class.
- The investigator believes the subject is unsuitable for participating in this clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yu Chen
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200072
Hongxia Wang
About this study
Official title: An Open-label, Phase I Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of Pegylated Arginine Deiminase Dimer (PA5) Injection in Patients With Advanced Solid Tumors
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?
Read more
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.
Read the detailed description
This is an open-label, single-arm Phase I clinical study evaluating dose escalation and expansion of PA5 monotherapy in patients with advanced solid tumors. The study consists of two parts: a dose escalation phase to determine the safety, tolerability, and PK/PD profile of PA5, and a dose expansion phase to further assess its safety, pharmacodynamics, and efficacy. The study aims to define the effective dose range for PA5 monotherapy and provide a basis for future Phase II studies (monotherapy or combination therapy). A total of 31-49 participants will be enrolled (13-25 in escalation, 18-24 in expansion).
- Conditions
- Advanced Solid Tumors, Cancer
- Being tested
- PA5
- Keywords
- Advanced solid tumors, Pegylated Arginine Deiminase Dimer, PA5, Arginine Deiminase
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA5Biological
Also called Pegylated Arginine Deiminase Dimer
Administration 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.
| Study group | Role | What they receive |
|---|---|---|
| PA5 | Experimental | 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) at dose escalation levels of 0.1, 0.2, 0.4, 0.8, or 1.2 mg/kg.
In expansion phase, participants will receive PA5 via intravenous infusion with the frequency determined based on the results of the escalation phase. Receives: Biological: PA5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT)
Measured: At the end of Cycle 1 (each cycle is 28 days)
The maximum tolerated dose (MTD)
Measured: At the end of Cycle 1 (each cycle is 28 days)
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.
Measured: 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)
Recommended phase 2 dose (RP2D) of PA5
Determine RP2D based on the efficacy and safety of PA5 during the dose escalation and expansion phases
Measured: On Day 28 of Cycle 7 (each cycle is 28 days) or at the end of the treatment (whichever occurs earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start14 Nov 2025
- Primary completion2 Feb 2027 (estimated)
- Study completion4 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702162
- Sponsor's protocol ID
- PA5-A101
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of Pegylated Arginine Deiminase Dimer (PA5) Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07702162
- Acronym / sponsor ID
- PA5-A101
- Conditions
- Advanced Solid Tumors, Cancer
- Keywords
- Advanced solid tumors, Pegylated Arginine Deiminase Dimer, PA5, Arginine Deiminase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 4 Jun 2027 (estimated)
- First posted
- 14 Jul 2026 (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.
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.
Detailed description
This is an open-label, single-arm Phase I clinical study evaluating dose escalation and expansion of PA5 monotherapy in patients with advanced solid tumors. The study consists of two parts: a dose escalation phase to determine the safety, tolerability, and PK/PD profile of PA5, and a dose expansion phase to further assess its safety, pharmacodynamics, and efficacy. The study aims to define the effective dose range for PA5 monotherapy and provide a basis for future Phase II studies (monotherapy or combination therapy). A total of 31-49 participants will be enrolled (13-25 in escalation, 18-24 in expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PA5 | Experimental | Biological: PA5In 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) at dose escalation levels of 0.1, 0.2, 0.4, 0.8, or 1.2 mg/kg. In expansion phase, participants will receive PA5 via intravenous infusion with the frequency determined based on the results of the escalation phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Expected life expectancy of at least 12 weeks.
Key exclusion criteria (10 listed)
- 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.
- Clinically significant active bacterial, fungal, or viral infection.
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 |
|---|---|---|
| PA5Also: Pegylated Arginine Deiminase DimerAdministration 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. | Biological | PA5 |
Primary outcome
Incidence of dose limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The maximum tolerated dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Adverse Events (AEs)
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)
including the incidence of overall and categorized AEs, severity (graded according to NCI CTCAE v5.0), seriousness, relationship to PA5 treatment, duration, and outcome.
Recommended phase 2 dose (RP2D) of PA5
Time frame: On Day 28 of Cycle 7 (each cycle is 28 days) or at the end of the treatment (whichever occurs earlier)
Determine RP2D based on the efficacy and safety of PA5 during the dose escalation and expansion phases
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PA5 in people with Advanced Solid Tumors and Cancer, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 2 sites 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Sun (+86-13983367811, sunj@pegbiocq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 4 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 14 Jul 2026.