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A Clinical Study of PA5 in Patients With Advanced Solid Tumors

NCT07702162 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-07-14

No results posted yet for this study

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. 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.

Conditions

Interventions

BIOLOGICAL

PA5

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.

Sponsors & Collaborators

  • Chongqing Peg-Bio Biopharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2027-02-02
Completion
2027-06-04

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07702162 on ClinicalTrials.gov