PA5 in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1 study examines escalating doses and later expansion of PA5 monotherapy in adults with advanced solid tumors that have progressed after standard therapy. Participants receive intravenous PA5 in a dose-escalation format to determine safety, tolerability, and PK/PD, followed by a dose-expansion phase to further assess safety and preliminary efficacy. The study aims to establish the safe and potentially effective dose range to inform Phase II trials, with 31-49 participants planned across both phases. Primary questions focus on safety, tolerability, maximum tolerated dose, and recommended Phase II dose for PA5 monotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jing Sun
• Email: sunj@pegbiocq.com
• Phone: +86-13983367811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.