Clinical Observation on the Safety and Efficacy of Cardonilmab in the Treatment of Second-line and Above Advanced Melanoma and Advanced Renal Cancer

Study Purpose

Safety and efficacy of Cardonilmab as a second-line or above treatment in patients with advanced malignant melanoma and renal cell carcinoma. To investigate the safety and efficacy of cardunnilizumab in the treatment of advanced mucosal, acral and cutaneous malignant melanoma and advanced renal cell carcinoma. Primary end point: objective response rate (ORR) Secondary end point: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), incidence of treatment-related adverse events Exploratory study end point: efficacy related marker exploration, gut microbiota or metabolomics changes

Recruitment Criteria

Accepts Healthy Volunteers

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

Yes
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 - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Able to sign informed consent; 2. Age ≥18 years, ≤75 years; 3. Cohort 1: histopathologically diagnosed metastatic mucosal or acro-type malignant melanoma with at least second-line prior treatment, including but not limited to PD-1 or PDL1 monoclonal antibody; Cohort 2: histopathologically confirmed metastatic renal cancer with at least second-line prior treatment. 4. There is at least one radiologically measurable lesion according to RECIST1.1 efficacy evaluation criteria; 5. ECOG physical strength score 0-2 points; 6. Expected survival ≥3 months; 7. Major organ function meets the following criteria 7 days before treatment: A. Blood routine: neutrophil absolute value ≥1.5×109/L; Hemoglobin ≥80g/L; Platelet ≥90×109/L; B. Blood biochemistry: total bilirubin ≤1.5ULN; ALT and AST≤2.5ULN (Subjects with liver metastases allow ALT or AST≤5×ULN); Serum creatinine ≤1.5ULN or creatinine clearance ≥50ml/min; C. Left ventricular ejection fraction ≥50%; D. Activated partial thromboplastin time (APTT), International Normalized ratio (INR), prothrombin time (PT) ≤1.5ULN; E. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled F. Myocardial enzyme profiles and troponin within the normal range (simple laboratory abnormalities that are not clinically significant are also allowed to be included) 8. Women of reproductive age should use effective contraception during the study period and for 6 months after the end of the study; A negative serum or urine pregnancy test within 7 days prior to study enrollment; Non-lactating patients; Men should agree to use effective contraception during the study period and for 6 months after the end of the study period; 9. Patients were able to follow the study plan and protocol requirements.

Exclusion Criteria:

1. The presence of symptomatic or untreated known brain metastases or other CNS metastases. Central nervous system metastases that have been shown to be stable or improved after complete resection and/or radiotherapy are not an exclusion criterion, provided that computed tomography (CT) shows stability for at least 4 weeks prior to screening, there is no evidence of cerebral edema and no need for corticosteroids or anticonvulsants; 2. Uncontrolled active infections at the time of screening (such as sepsis, bacteremia, fungemia, viremia, etc.); 3. Active viral hepatitis B or C: Hepatitis B (defined as the presence of hepatitis B core antibody [HBcAb] or hepatitis B surface antigen [HBsAg], and hepatitis B virus DNA [HBV-DNA]) > 1000cps/mL or > lower limit of quantification according to local laboratory methods); Or test positive for hepatitis C (hepatitis C antibodies and/or hepatitis C virus RNA ([RNA]); 4. HIV-infected patients; 5. The patient is known to have systemic vasculitis (e.g., Wegener granuloma, polyarteritis nodosa), systemic lupus erythematosus, co-active or uncontrolled autoimmune disease (e.g., Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (e.g., HIV infection or severe symptoms) Infectious diseases, etc.); 6. The patient has a known history of other malignancies; 7. Those who are known to be allergic to the active ingredients or excipients of cardonilizumab in this study; 8. Previously received anti-CTLA-4 specific antibody drug treatment; 9. is currently participating in an interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 10. Received systemic systemic treatment with proprietary Chinese medicines with anticancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration; 11. Patients who had systematically used large amounts of glucocorticoids in the 4 weeks prior to enrollment (except those who used inhaled hormones); 12. Serious mental disorders; 13. Patients with serious heart, liver, renal insufficiency, diabetes and other diseases; 14. Pregnant or lactating women; 15. Medical history or evidence of disease that may interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The investigator considers other potential risks unsuitable for participation in the 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.

NCT06670300
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 2
Lead Sponsor

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

YongZhang
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.

Other
Overall Status Not yet recruiting
Countries China
Conditions

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

Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal Cancer
Arms & Interventions

Arms

Experimental: cardonilimab for advanced melanoma

Subjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study.

Experimental: cardonilimab for advanced kidney cancer

Subjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study.

Interventions

Drug: - cardonilimab

Subjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study.

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

Zhengzhou, China

Status

Address

the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, ,

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