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.
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
- Conditions the study is for
- Melanoma, Immune-related Adverse Event, Immune Checkpoint Inhibitor
- 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
- Are there results?
- Not yet: the study is under way
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.
China2 sites, 2 recruiting
- 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
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:
- Age ≥60 years old;
- Pathologically confirmed as inoperable or metastatic melanoma;
- one or more lesions evaluable by RECIST1.1 standards.
- The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2;
Main exclusion criteria:
- Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months;
- Received thymosin class drug treatment within 3 months before signing the informed consent.
- 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 group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Thymosin 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.
Objective Response Rate
defined as the best overall response of complete remission or partial remission,
Measured: up to 24 weeks
Secondary outcomes (4)
Progression-Free Survival (PFS)
Measured: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.
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.
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.
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.
- First posted12 Jun 2026
- Study start30 May 2023
- Primary completion30 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xizhi wen, Sun Yat-sen University
- Investigators
- Xiaoshi Zhang, phD, Study directorPenghui Zhou, PhD, Principal investigatorYa Ding, PhD, Principal investigatorDandan Li, PhD, Principal investigatorJingjing Zhao, PhD, Principal investigator
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 23045967Romani 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 16741252Maio 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 20194853Giuliani 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT07644897
- Acronym / sponsor ID
- xizhiwen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Age ≥60 years old;
- Pathologically confirmed as inoperable or metastatic melanoma;
- one or more lesions evaluable by RECIST1.1 standards.
- The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2;
Main exclusion criteria:
- Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months;
- Received thymosin class drug treatment within 3 months before signing the informed consent.
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Thymosin Alpha 1 and Anti-PD-1 monoclonal antibodyThymosin Alpha 1 and anti-PD-1 monoclonal antibody |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymosin Alpha 1 and Anti-PD-1 monoclonal antibodyThymosin 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 | Drug | intervention group |
Primary outcome
Objective Response Rate
Time frame: up to 24 weeks
defined as the best overall response of complete remission or partial remission,
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.
overall survival (OS)
Time frame: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.
Adverse Events (AEs)
Time frame: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.
Duration of Response (DOR),
Time frame: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 23045967Garaci 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.
- Results publication: PubMed 16741252Romani 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.
- Results publication: PubMed 20194853Maio 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.
- Results publication: PubMed 10741392Giuliani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoshi Zhang, phD study director
Penghui Zhou, PhD principal investigator
Ya Ding, PhD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xizhi Wen, PhD (+8602087343381, wenxzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07644897, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.