Clinical trial NCT06639347: A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma
Official title: An Open Label, Multicenter, Phase Ib/Il Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Urothelial Carcinoma
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-A2102 with antitumor therapy
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer
timeFrame: Up to approximately 5 years
measure: Phase I: Incidence and severity of adverse events
timeFrame: Up to approximately 5 years
measure: Phase II: ORR by investigator assessment
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Phase I: ORR by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase I: DCR by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase I: DoR by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase I: PFS by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase I: OS by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase I: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin
timeFrame: Up to approximately 5 years
measure: Phase I: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)
timeFrame: Up to approximately 5 years
measure: Phase II: DCR by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase II: DoR by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase II: PFS by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase II: OS by investigator assessment
timeFrame: Up to approximately 5 years
measure: Phase II: Incidence and severity of adverse events
timeFrame: up to 5 years
measure: Phase II: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin
timeFrame: Up to approximately 5 years
measure: Phase II: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: