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NCT Number: NCT05765032

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University Cancer Institute& Hospital

Tianjin, Tianjin Municipality, 300060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: up to 21 days of cycle 1

  2. Determination of Recommended Phase II dose (RP2D) （Phase 1b）

    Time frame: Up to 21 days of cycle 1

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

  6. Overall survival

    Time frame: approximately 12months after last patient enrolled.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 13, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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