Clinical Trial of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers

NCT ID: NCT05333276

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-29
• Study Completion Date: 2024-05-31

Brief Summary

TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-programmed cell death protein 1 (PD-1) antibody.

Conditions

Advanced Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3602 Capsule + AK105 Injection

TQB3602 capsule administered orally on day 1, 8 in 21-day cycle; every three weeks intravenous (IV) for one times of AK105 injection.

Group Type: EXPERIMENTAL

TQB3602 Capsule + AK105 Injection

Intervention Type: DRUG

TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody.

Interventions

TQB3602 Capsule + AK105 Injection

TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Nong Yang

Changsha, Hunan, China

Countries

China

Other Identifiers

TQB3602-AK105-I-01

Identifier Type: -

Identifier Source: org_study_id