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MelanomaPhase 2NCT07644897

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

A Phase 2 study testing Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody in people with Melanoma and Immune-related Adverse Event, run by Sun Yat-sen University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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 . Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesChina
Study dates
30 May 2023to 30 Sep 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 60 years or older;
  • Diagnosis of malignant melanoma confirmed by pathological histology or cytology examination.
  • According to the 8th edition of AJCC staging, patients with unresectable stage III or IV melanoma;
  • One or more lesions evaluable by RECIST1.1 standards.
  • The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States has a score range of 0-2.
  • Total bilirubin ≤1.5× upper limit of normal (ULN); AST and AST <2.5× upper limit of normal (ULN).(No liver metastasis), or <5 times the upper limit of normal (ULN) (with liver metastasis);
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  • Patients with recurrent metastasis who have not previously received immunotherapy such as PD-1, PD-L1, CTLA-4 antibodies，also allowed for the enrollment of patients who had used adjuvant/neoadjuvant therapies
  • If the adjuvant or neoadjuvant treatment plan includes PD(L)-1 or CTLA-4 monoclonal antibodies, it is required that only those who progress more than 6 months after the end of the treatment plan can be included in the study group.
  • If the adjuvant or neo-adjuvant treatment plan does not include PD(L)-1 or CTLA-4 monoclonal antibodies, patients who progress during the adjuvant treatment are allowed to participate in the study.
  • Has signed the informed consent form, able to comply with the study protocol and follow-up plan.

Who cannot join

  • Received treatment involving PD-1, PD-L1, or CTLA-4 antibody regimen within the past 6 months;
  • Patients who have received treatment with thymosin, thymopentin, or thymosin a-1d within 3 months prior to enrollment.
  • Presence of symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. For subjects with previously treated CNS metastases, if the subject's condition is stable (no evidence of radiographic progression for at least weeks prior to the first administration of the study intervention, and all neurological symptoms have returned to baseline), repeat radiographic examination confirms no evidence of new brain metastases or enlargement of existing brain metastases, and no need for steroid treatment for at least 14 days prior to the first administration of the study intervention, they may participate in the study.
  • Patients with active systemic autoimmune diseases requiring systemic treatment (i.e., using immunomodulators, corticosteroids, or immunosuppressants). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment.
  • Has a history of immunodeficiency, including testing positive for HIV, or suffering from other acquired or congenital immunodeficiency diseases, or has a history of organ transplantation and bone marrow transplantation.
  • 6）Allergic to the investigational drug or its components; 7）Presence of active infection requiring systemic treatment; 8) Uncontrolled internal medical complications, such as unstable congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accidents, and hemodynamically unstable arrhythmias, etc.
  • 9) The investigator deems them unsuitable for inclusion.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xizhi Wen, PhD contact

+8602087343381

wenxzh@sysucc.org.cn

China2 sites, 2 recruiting

  • Sun yat-sen uniersity

    Guangzhou, Guangdong, 510000

    Xizhi Wen, phD, +8602087343381, wenxzh@sysucc.org.cn

    Recruiting

  • Nanshan hospital

    Shenzhen, Guangdong, 518000

    qiming zhou, phD

    Recruiting

Other trials in China

About this study

Primary Objective:

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

Read more

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)

Being tested
Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thymosin Alpha 1 and Anti-PD-1 monoclonal antibodyDrug

    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

Study groups in NCT07644897
Study groupRoleWhat they receive
intervention groupExperimentalThymosin Alpha 1 and anti-PD-1 monoclonal antibody
Receives: Drug: Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    defined as the best overall response of complete remission or partial remission,

    Measured: up to 24 weeks

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    Measured: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.

  2. overall survival (OS)

    defined as the time from enrollment to death due to any cause.

    Measured: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.

  3. Adverse Events (AEs)

    Signs, symptoms or abnormal laboratory test related to treatment

    Measured: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.

  4. Duration of Response (DOR),

    Measured: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start30 May 2023
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07644897
Sponsor's protocol ID
xizhiwen
Status last verified
Jun 2026
First submitted
21 Nov 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garaci E, Pica F, Serafino A, Balestrieri E, Matteucci C, Moroni G, Sorrentino R, Zonfrillo M, Pierimarchi P, Sinibaldi-Vallebona P. Thymosin alpha1 and cancer: action on immune effector and tumor target cells. Ann N Y Acad Sci. 2012 Oct;1269:26-33. doi: 10.1111/j.1749-6632.2012.06697.x.

    PubMed 23045967

  • Romani L, Bistoni F, Perruccio K, Montagnoli C, Gaziano R, Bozza S, Bonifazi P, Bistoni G, Rasi G, Velardi A, Fallarino F, Garaci E, Puccetti P. Thymosin alpha1 activates dendritic cell tryptophan catabolism and establishes a regulatory environment for balance of inflammation and tolerance. Blood. 2006 Oct 1;108(7):2265-74. doi: 10.1182/blood-2006-02-004762. Epub 2006 Jun 1.

    PubMed 16741252

  • Maio M, Mackiewicz A, Testori A, Trefzer U, Ferraresi V, Jassem J, Garbe C, Lesimple T, Guillot B, Gascon P, Gilde K, Camerini R, Cognetti F; Thymosin Melanoma Investigation Group. Large randomized study of thymosin alpha 1, interferon alfa, or both in combination with dacarbazine in patients with metastatic melanoma. J Clin Oncol. 2010 Apr 1;28(10):1780-7. doi: 10.1200/JCO.2009.25.5208. Epub 2010 Mar 1.

    PubMed 20194853

  • Giuliani C, Napolitano G, Mastino A, Di Vincenzo S, D'Agostini C, Grelli S, Bucci I, Singer DS, Kohn LD, Monaco F, Garaci E, Favalli C. Thymosin-alpha1 regulates MHC class I expression in FRTL-5 cells at transcriptional level. Eur J Immunol. 2000 Mar;30(3):778-86. doi: 10.1002/1521-4141(200003)30:33.0.CO;2-I.

    PubMed 10741392

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