Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Study ID
NCT05187338
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab +pembrolizumab +durvalumab — DRUG
    This study has 3 subgroups: 1. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg/kg via vein, every 3 weeks. 2. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg/kg via sustained (10min) micro-pump infusion via artery, every 3 weeks. 3. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 50-150mg via intra-tumor fine needle injection in 5 min, every 3 weeks.

Study Details

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (IV), artery (IA) or intra-tumor (IT).

Key Dates

First listed
Jan 11, 2022
Start date
Nov 1, 2021
Status verified
Jun 2024
Primary completion
Oct 30, 2029
Completion
Oct 30, 2035

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 3 drugs
    Three antibodies combination against PD1, PDL1, and CTLA4.

Primary Outcome Measure

Safety of 3 drugs combination treatment [ Time Frame: 5 years ]

Central Contacts

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