Status:
UNKNOWN
Clinical Trial of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-programmed cell death protein 1 (PD-1) antibody.
Eligibility Criteria
Inclusion
- 1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- 2 Age ≥ 18; Eastern Cooperative Oncology Group perfomance status score: 0-2; at least 3 months expected survival period.
- 3 Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
- 4 Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 per CTCAE v5.0 except for AEs not constituting a safety risk by investigator judgment.
- 5 Must have adequate organ and bone marrow function.
- 6 Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for at least 6 months after the last dose of assigned treatment.
Exclusion
- 1 Subjects with other malignancies currently or suffered within 3 years. The following two conditions can be enrolled: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
- 2 Sujects with multiple factors affecting oral administration；
- 3 Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment；
- 4 Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before first administration；
- 5 Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05333276
Start Date
July 29 2022
End Date
May 1 2024
Last Update
July 27 2023
Active Locations (2)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Nong Yang
Changsha, Hunan, China, 410000