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A Study of SHR-A1904 in Patients With Advanced Solid Cancer

Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04877717
Collaborator
(none)
94
Enrollment
1
Location
1
Arm
30
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with advanced solid cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
SHR-A1904 monotherapySHR-A1904 monotherapy
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-A1904

Drug: SHR-A1904
SHR-A1904

Outcome Measures

Primary Outcome Measures

  1. Determine the Maximum Tolerated Dose of SHR-A1904 [up to 1 year]

Secondary Outcome Measures

  1. Maximum concentration (Cmax) [up to 1 year]

  2. Time to maximum concentration (Tmax) [up to 1 year]

  3. Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) [up to 1 year]

  4. Anti-drug antibody (ADA) of SHR-A1904 [up to 1 year]

  5. Objective response rate (ORR) [up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

  2. Males or females aged 18-75 years old

  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

  4. Has a life expectancy≥ 3 months

  5. Has at least one measurable lesion as defined by RECIST v1.1

  6. Pathologically confirmed advanced solid cancer

Exclusion Criteria:

  1. Plan to receive any other anti-tumor treatments during the study treatment period of this study

  2. Received other clinical investigational products or treatments within 4 weeks before the first dose of the study

  3. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study

  4. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study

  5. Subjects with known brain metastases

  6. Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study

  7. presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-Sen University Cancer Center Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Hengrui Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04877717
Other Study ID Numbers:
  • SHR-A1904-I-101
First Posted:
May 7, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 4, 2021