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Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors

NCT07053904 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-07-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn the safety of sequential treatment with P1101 and P1801 in advanced solid tumors. It will also learn the maximum tolerated dose (MTD) of P1801. The main questions it aims to answer are:

To evaluate the safety and tolerability of sequential treatment with P1101 and P1801 in patients with advanced solid tumors.

To determine the maximum tolerated dose (MTD) of P1801.

Participants will:

Ttreated by 6 doses of P1101 once per 2 weeks (Q2W) at 450 mcg and then followed by the treatment with P1801 Q2W at the pre-determined dose level by cohort during each 28-day treatment cycle in the Dose Escalation Phase (Cohort 1-5).

Once the MTD have been declared and for further characterize safety and clinical activity, additional patients with RCC or CRC will be enrolled into the tumor-specific expansion cohorts to receive the sequential administration of 6 doses of P1101 Q2W at 450 ug followed by P1801 Q2W at MTD.

Patients will visit the clinic every two weeks during the treatment period for drug administration and physical examinations.

All patients must complete the safety follow-up visits at the 30-, 90-, and 150-day after the last dose of study treatment.

Upon completion of the safety follow up, patients will be followed for survival every 12 weeks until death or until the end of the study is reached, unless they withdraw consent or are lost to follow-up.

Conditions

Interventions

DRUG

Sequential use of P1101 and P1801

Sequential use of ropeginterferon alfa-2b and P1801 (anti PD-1 antibody drug)

Sponsors & Collaborators

  • Efficient Pharma Management Corp.

    collaborator INDUSTRY

  • PharmaEssentia

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Taiwan

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 NCT07053904 on ClinicalTrials.gov