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

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

Official Title
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A Phase I Study of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers

Conditions
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Advanced Cancers

Intervention / Treatment
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* Drug: TQB3602 Capsule + AK105 Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQB3602 Capsule + AK105 Injection<br>TQB3602 capsule administered orally on day 1, 8 in 21-day cycle; every three weeks intravenous (IV) for one times of AK105 injection. | Drug: TQB3602 Capsule + AK105 Injection<br>* TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicity (DLT) | DLT will be assessed during the first 21 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (21 days) of treatment. | During the first 21 days | 
| Maximum tolerated dose (MTD) | MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT). | During the first 21 days | 
| Recommended phase II dose (RP2D) | The RP2D was the maximum tolerated dose (MTD) or less. | Up to Cycle 28 (Cycle Length= 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events (AEs) and serious adverse events (SAEs) | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | From the time of informed consent signed to 90 days after the last dose | 
| Progression-free survival (PFS) | Defined as the time from the first dose of TQB3602 and AK105 to the first occurrence of disease progression or death from any cause. | up to 2 years | 
| Disease control rate (DCR) | Defined as the proportion of subjects with CR (Complete response), PR (Partial response), or SD (Stable Disease). | up to 2 years | 
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | up to 2 years | 
| Overall survival (OS) | OS is defined as the time between the date of first administration and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. | up to 5 years |