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

Advanced Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05333276
• Other study ID #: TQB3602-AK105-I-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 29, 2022
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancers
• Neoplasms

Intervention

Drug:
• TQB3602 Capsule + AK105 Injection
TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody.

Locations

Country	Name	City	State
China	Nong Yang	Changsha	Hunan
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Recommended phase II dose (RP2D)	The RP2D was the maximum tolerated dose (MTD) or less.	Up to Cycle 28 (Cycle Length= 21 days)
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	up to 2 years
Secondary	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