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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Cancers
• Intervention / Treatment: Drug: TQB3602 Capsule + AK105 Injection

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Zhang, Doctor; Phone Number: 020-87343458; Email: zhangli@sysucc.org.cn
• Study Contact Backup: Name: Nong Yang, Doctor; Phone Number: 0731-89762320; Email: yangnongpi@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
      • Contact: Li Zhang, Doctor; Phone Number: 02087343458; Email: zhangli@sysucc.org.cn
  • Hunan
    • Changsha, Hunan, China, 410000
      • Nong Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: TQB3602 Capsule + AK105 Injection; TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody.

What is the study measuring?

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
Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	up to 2 years
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
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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB3602-AK105-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No