Clinical trial NCT05765032: Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
Official title: An Open Label, Multicenter, Phase Ib/II Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-75 years;
2. Be able to provide fresh or archived tumour tissue.
3. Ph 1b: clinically or pathologically diagnosed advanced solid tumour . Ph II: Histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer
4. With at least one measurable lesion (in accordance with RECIST v1.1)
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
6. With a life expectancy ≥ 12 weeks.
7. Sufficient organ functions.
8. Women of childbearing potential (WOCBP) and Male subjects whose partner are women of childbearing potential must agree to use a reliable and valid contraceptive method.

Exclusion Criteria:

1. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression.
2. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
3. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years
4. Hypertension that can not be well controlled through antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.
5. with any active or known autoimmune disease
6. with active pulmonary tuberculosis infection

Primary outcomes:
measure: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. （Phase 1b）
timeFrame: up to 21 days of cycle 1
measure: Determination of Recommended Phase II dose (RP2D) （Phase 1b）
timeFrame: Up to 21 days of cycle 1
measure: Objective Response Rate as Assessed by the Investigator according to RECIST v1.1（Phase II）
timeFrame: From baseline to progressive disease or death (approximately 1 year)
Secondary outcomes:
measure: Objective Response Rate as Assessed by the Investigator according to RECIST v1.1e (Ph1b only),
timeFrame: From baseline to progressive disease or death (approximately 1 year)]
measure: Duration of Response as Assessed by the Investigator according to RECIST v1.1
timeFrame: From baseline to progressive disease or death (approximately 1 year)
measure: Disease Control Rate as Assessed by the Investigator according to RECIST v1.1
timeFrame: From baseline to progressive disease or death (approximately 1 year)
measure: Time to Response as Assessed by the Investigator according to RECIST v1.1
timeFrame: From baseline to progressive disease or death (approximately 1 year)
measure: Progression-free Survival as Assessed by the Investigator according to RECIST v1.1
timeFrame: From baseline to progressive disease or death (approximately 1 year)
measure: Overall survival
timeFrame: approximately 12months after last patient enrolled.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute& Hospital
state: Tianjin
Study officials:
References: