Advanced Cancers
Conditions
Brief summary
TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-programmed cell death protein 1 (PD-1) antibody.
Interventions
DRUGTQB3602 Capsule + AK105 Injection
TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity (DLT) | During the first 21 days | 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. |
| Maximum tolerated dose (MTD) | During the first 21 days | 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). |
| Recommended phase II dose (RP2D) | Up to Cycle 28 (Cycle Length= 21 days) | The RP2D was the maximum tolerated dose (MTD) or less. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | up to 2 years | Defined as the time from first documented response to documented disease progression. |
| Number of patients with adverse events (AEs) and serious adverse events (SAEs) | From the time of informed consent signed to 90 days after the last dose | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Overall survival (OS) | up to 5 years | 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. |
| Progression-free survival (PFS) | up to 2 years | Defined as the time from the first dose of TQB3602 and AK105 to the first occurrence of disease progression or death from any cause. |
| Disease control rate (DCR) | up to 2 years | Defined as the proportion of subjects with CR (Complete response), PR (Partial response), or SD (Stable Disease). |
Countries
China
Outcome results
None listed