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

NCT07644897 | Recruiting Phase 2 DMC

• 1 other identifier: xizhiwen
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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. 1.Age ≥60 years old;
2. 2.Pathologically confirmed as inoperable or metastatic melanoma;
3. 3.one or more lesions evaluable by RECIST1.1 standards.
4. 4.The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2;
5. 5.Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months;
6. 6.Received thymosin class drug treatment within 3 months before signing the informed consent.
7. 7.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.

Conditions

Melanoma; Immune-related Adverse Event; Immune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

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

  up to 24 weeks

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

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

• overall survival (OS)

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

• Adverse Events (AEs)

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

• Duration of Response (DOR),

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

Study Arms (1)

intervention group

EXPERIMENTAL

Thymosin Alpha 1 and anti-PD-1 monoclonal antibody

Drug: Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody

Interventions

Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody DRUG

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

intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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.
• ）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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Sun yat-sen uniersity

Guangzhou, Guangdong, 510000, China

RECRUITING

Nanshan hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 23045967 RESULT

• 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.

  PMID: 16741252 RESULT

• 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.

  PMID: 20194853 RESULT

• 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.

  PMID: 10741392 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Xiaoshi Zhang, phD

  STUDY DIRECTOR

• Penghui Zhou, PhD

  PRINCIPAL INVESTIGATOR

• Ya Ding, PhD

  PRINCIPAL INVESTIGATOR

• Dandan Li, PhD

  PRINCIPAL INVESTIGATOR

• Jingjing Zhao, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xizhi Wen, PhD

CONTACT

+8602087343381; wenxzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: June 12, 2026
• Study Start: May 30, 2023
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)