A Clinical Study of T3011 in Subjects With Advanced Melanoma

Study Purpose

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects with advanced melanoma; 2. At least one measurable lesion; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 4. Expected survival > 12 weeks; 5. Laboratory inspection meets the requirements; 6. For women of childbearing potential, the serum pregnancy test results must be negative within 7 days prior to the first dose,and effective contraceptive measures must be taken from signing the informed consent form (ICF) until at least 6 months after the last dose; 7. Male subjects of childbearing potential agree to use effective contraception from signing the ICF until at least 6 months after the last dose; In addition, male subjects must agree not to donate sperm during this period; 8. Understand and voluntarily sign the ICF,willing and able to comply with all experimental requirements.

Exclusion Criteria:

1. Subjects who have received other antitumor therapy within the prescribed time prior to the first dose; 2. Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment. 3. At screening, subjects with a history or evidence of high risk cardiovascular disease; 4. Subjects with persistent or active infection requiring intravenous anti-infective therapy; 5. Subjects with autoimmune diseases or a history of autoimmune diseases; 6. Subjects with known psychiatric disorders that may affect trial compliance; 7. Subjects who have pleural effusion, pericardial effusion, or ascites before starting treatment and require puncture drainage, or who had received puncture drainage within the specified time before starting the study treatment; 8. Subjects requiring systemic treatment with anti-HSV drugs during the study period; 9. Subjects who have received live or attenuated vaccines within the prescribed time prior to the first dose, or who plan to receive such vaccines during the study period; Subjects who have received any tumor vaccine in the past; 10. Subjects who had undergone major surgery within the prescribed time before the first dose,and had not recovered from surgery-related adverse reactions or were still in the postoperative recovery period,or who plan to undergo major surgery during the study period; 11. Subjects with a history of drug use,drug abuse or alcohol abuse within the year prior to signing the ICF; 12. Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period; 13. The investigator considers it inappropriate to participate in this study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06214156
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Pharmaceuticals Holding Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Melanoma
Arms & Interventions

Arms

Experimental: T3011

Interventions

Biological: - T3011

T3011 will be given intratumorally, Q2W;

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, ,

Site Contact

Jun Guo

guoj307@126.com

0086-010-88196370

Bengbu, China

Status

Recruiting

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, ,

Site Contact

Mingxi Wang

guoj307@126.com

0086-010-88196370

Jilin Cancer Hospital, Changchun, China

Status

Recruiting

Address

Jilin Cancer Hospital

Changchun, ,

Site Contact

Xueying Zhang

guoj307@126.com

0086-010-88196370

Chengdu Shangjin Nanfu Hospital, Chengdu, China

Status

Recruiting

Address

Chengdu Shangjin Nanfu Hospital

Chengdu, ,

Site Contact

Yaotiao Deng

guoj307@126.com

0086-010-88196370

Fujian Cancer Hospital, Fuzhou, China

Status

Recruiting

Address

Fujian Cancer Hospital

Fuzhou, ,

Site Contact

Yu Chen

guoj307@126.com

0086-010-88196370

The Third People's Hospital of Zhengzhou, Zhengzhou, China

Status

Recruiting

Address

The Third People's Hospital of Zhengzhou

Zhengzhou, ,

Site Contact

Xianbin Liang

guoj307@126.com

0086-010-88196370

Sun Yat-sen University Cancer Center, Zhongshan, China

Status

Recruiting

Address

Sun Yat-sen University Cancer Center

Zhongshan, ,

Site Contact

Xiaoshi Zhang

guoj307@126.com

0086-010-88196370

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