Vedisertib (RC48/ADC) Combined With Toripalimab in Bladder-preserving Treatment (NCT07201675) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Vedisertib (RC48/ADC) Combined With Toripalimab in Bladder-preserving Treatment
59 participantsStarted 2025-12-01
Plain-language summary
This is a phase II clinical study to evaluate the efficacy of RC48-ADC combined with toripalimab bladder-sparing therapy.
The RC48-ADC dose in this study is 2.0 mg/kg Q2W and toripalimab is 3 mg/kg Q2W.
This study plans to enroll 59 participants. The participants will start drug therapy within 2 weeks after the first diagnostic resection in the first stage, receiving RC48-ADC combined with toripalimab 3 times. At the 8th week after enrollment, the second stage of cystectomy was performed, and RC48-ADC combined with toripalimab was treated every two weeks thereafter for a total of 3 treatments. After the completion of the two-stage treatment, the participants should be discharged from the group by cystoscopy or other imaging examinations. On the contrary, if the participants have complete remission or partial remission, continue to the third stage of treatment, that is, receive RC48-ADC combined with toripalimab every two weeks for a total of 6 treatments, followed by cystoscopy, imaging, or a third cystectomy. If the participants achieve complete remission of the disease, maintenance immunotherapy will be given for 12 months. If the participants show that there is still a tumor, the participants will be discharged from the group for other treatments. Due to disease progression, death, participants voluntarily requested termination of study treatment, toxicity intolerance, initiation of new anti-tumor therapy, pregnancy, serious violation of the study process stipulated by the protocol, termination of study treatment determined by the investigator based on the best interests of the participants, loss to follow-up, whichever occurred first.
During the study, the first and second electrotoxic tissues were sequenced using RNA and single-cell sequencing, and ctDNA was tested in urine before treatment, in the third month, and in the sixth month.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily agree to participate in the study and sign the informed consent form;
✓. Male or female, age ≥ 18 years;
✓. Expected survival ≥ 18 months;
✓. Pathological and imaging diagnosis of cT2-4aN0M0MIBC;
✓. Subjects are able to provide specimens of tumor primary lesions detected by PD-L1 and HER2; HER2 IHC 1 or 2 or 3 ;
✓. No previous systemic therapy;
✓. ECOG performance status score of 0 or 1 point;
✓. Adequate cardiac, bone marrow, liver, and renal function (based on normal values at the study center):
Exclusion criteria
✕. History of malignant tumors other than urothelial carcinoma, except for the following two conditions:
✕. Patients have received potentially curative therapy and no evidence of the disease within 5 years;
What they're measuring
1
cCR (Clinical Complete response)
Timeframe: From date of randomization, follow-up once every 12 weeks until the date of first documented death, loss to follow-up, withdrawal of informed consent, whichever came first, assessed up to 60 months
✕. Successfully undergoing resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, and other carcinomas in situ;
✕. Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.);
✕. Previous allogeneic stem cell or parenchymal organ transplantation; Patients who have received other anti-tumor systemic therapy (including traditional Chinese medicine with anti-tumor indications) in the past, less than 4 weeks after the completion of treatment to before the use of this study, or who have not recovered to ≤ CTCAE grade 1 (except for alopecia and pigmentation);
✕. Previous or current congenital or acquired immunodeficiency disease;
✕. Active or previous documented autoimmune or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc.), vitiligo or asthma that has been completely resolved in childhood, and those who do not need any intervention in adulthood can be included;
✕. Use of systemic immunosuppressive drugs within 2 weeks prior to enrollment, or anticipation of need for systemic immunosuppressive drugs during the study, except for the following: