Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors

NCT05765032 | Active Not Recruiting Phase 1

• 1 other identifier: SHR-A1921-201
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. （Phase 1b）

  up to 21 days of cycle 1

• Determination of Recommended Phase II dose (RP2D) （Phase 1b）

  Up to 21 days of cycle 1

• Objective Response Rate as Assessed by the Investigator according to RECIST v1.1（Phase II）

  From baseline to progressive disease or death (approximately 1 year)

Secondary Outcomes (6)

• Objective Response Rate as Assessed by the Investigator according to RECIST v1.1e (Ph1b only),

  From baseline to progressive disease or death (approximately 1 year)]

• Duration of Response as Assessed by the Investigator according to RECIST v1.1

  From baseline to progressive disease or death (approximately 1 year)

• Disease Control Rate as Assessed by the Investigator according to RECIST v1.1

  From baseline to progressive disease or death (approximately 1 year)

• Time to Response as Assessed by the Investigator according to RECIST v1.1

  From baseline to progressive disease or death (approximately 1 year)

• Progression-free Survival as Assessed by the Investigator according to RECIST v1.1

  From baseline to progressive disease or death (approximately 1 year)

Study Arms (1)

SHR-A1921

EXPERIMENTAL

A1：SHR-A1921+Adebrelimab A2：SHR-A1921+Carboplatin A3：SHR-A1921+Cisplatin A4：SHR-A1921+Bevacizumab A5：SHR-A1921+Adebrelimab+Carboplatin A6：SHR-A1921+Adebrelimab+Cisplatin B1：SHR-A1921+Adebrelimab B2：SHR-A1921+Adebrelimab+Carboplatin/Cisplatin

Drug: SHR-A1921；

Interventions

SHR-A1921； DRUG

Drug: SHR-A1921 administered as an IV infusion Drug: Adebrelimab administered as an IV infusion Drug: Carboplatin administered as an IV infusion Drug: Cisplatin administered as an IV infusion Drug: Bevacizumab administered as an IV infusion

SHR-A1921

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-75 years;
• Be able to provide fresh or archived tumour tissue.
• Ph 1b: clinically or pathologically diagnosed advanced solid tumour . Ph II: Histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer
• With at least one measurable lesion (in accordance with RECIST v1.1)
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy ≥ 12 weeks.
• Sufficient organ functions.
• 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.

You may not qualify if:

• Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression.
• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
• 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
• 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.
• with any active or known autoimmune disease
• with active pulmonary tuberculosis infection

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute& Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 13, 2023
• Study Start: December 30, 2022
• Primary Completion: April 30, 2025
• Study Completion: February 28, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)