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Trial Title:
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma
NCT ID:
NCT06639347
Condition:
Advanced Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
SHR-A2102 with antitumor therapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A2102
Description:
SHR-A2102
Arm group label:
SHR-A2102 + Adebrelimab injection+SHR-8068 injection
Intervention type:
Drug
Intervention name:
Adebrelimab injection
Description:
Adebrelimab injection
Arm group label:
SHR-A2102 + Adebrelimab injection+SHR-8068 injection
Intervention type:
Drug
Intervention name:
SHR-8068 injection
Description:
SHR-8068 injection
Arm group label:
SHR-A2102 + Adebrelimab injection+SHR-8068 injection
Summary:
The study is being conducted to evaluate the safety, tolerability and efficacy of
SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To
explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Competent to comprehend, sign, and date an informed consent form.
2. Male or female subjects must be age 18 or older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Subjects must have histologically documented, unresectable locally advanced or
5. Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib,
subjects must have failed, be intolerant or refused the standard treatment; Phase
II, subjects must not have received systemic antitumor therapy for locally advanced
unresectable or metastatic urothelial carcinoma.
6. An archival tumor tissue sample or a fresh tissue sample should be provided.
7. Subjects must have measurable disease according to RECIST (version 1.1).
Exclusion Criteria:
1. Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
2. Subjects who have previously received TOPO1-based ADCs.
3. Subjects who have received anti-cancer treatment within 4 weeks prior the first dose
of study treatment.
4. Subjects who have received radiotherapy within 14 days , or chest radiotherapy >
30Gy within 6 months prior to the first dose of study drug.
5. Subjects with ongoing clinically significant toxicity associated with prior
treatment that has not resolved to ≤ Grade 1.
6. Subjects who have received systemic immunosuppressant treatment within 14 days prior
the first dose of study treatment.
7. Subjects who have known or suspected interstitial pneumonitis.
8. Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with
ICIs.
9. Subjects who have any active, known or suspected autoimmune diseases.
10. Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled
or moderate or above pleural effusion, or pericardial effusion.
11. Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Start date:
October 2024
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06639347
