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Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma

NCT07644897 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-06-12

No results posted yet for this study

Summary

Primary Objective:

To evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma .

Secondary Objective:

To evaluate the safety and tolerability of adenpeptide-α1 combined with PD-1 antibody in elderly patients with advanced melanoma .

Study Design：Open-label, single-arm, non-controlled clinical trial.

Primary Inclusion Criteria:

1. Age ≥60 years old;
2. Pathologically confirmed as inoperable or metastatic melanoma;
3. one or more lesions evaluable by RECIST1.1 standards.
4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2;

Main exclusion criteria:

1. Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months;
2. Received thymosin class drug treatment within 3 months before signing the informed consent.
3. Symptomatic, untreated central nervous system metastases. Treatment： Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc， three times per week, d8-21. Each 21 days is considered one cycle, for a total of 12 weeks.

Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W，4 cycles.

Primary study endpoints:

Objective Response Rate (ORR: CR+PR)

Secondary study endpoints:

Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS) Adverse Events (AEs)

Conditions

  • Melanoma
  • Immune-related Adverse Event
  • Immune Checkpoint Inhibitor

Interventions

DRUG

Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody

Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc，three times per week, d8-21 Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xiaoshi Zhang, phD

  • Penghui Zhou, PhD

  • Ya Ding, PhD

  • Dandan Li, PhD

  • Jingjing Zhao, PhD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2027-05-30
Completion
2027-09-30

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 NCT07644897 on ClinicalTrials.gov