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

NCT05333276 | Unknown Phase 1

• 1 other identifier: TQB3602-AK105-I-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Cancers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• Progression-free survival (PFS)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Overall survival (OS)

  up to 5 years

Study Arms (1)

TQB3602 Capsule + AK105 Injection

EXPERIMENTAL

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

Interventions

TQB3602 Capsule + AK105 Injection DRUG

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

TQB3602 Capsule + AK105 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
• Age ≥ 18; Eastern Cooperative Oncology Group perfomance status score: 0-2; at least 3 months expected survival period.
• 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.
• 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.
• Must have adequate organ and bone marrow function.
• 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.

You may not qualify if:

• 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\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• Sujects with multiple factors affecting oral administration；
• Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment；
• Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before first administration；
• Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.

Sponsors & Collaborators

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

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Nong Yang

Changsha, Hunan, 410000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 18, 2022
• Study Start: July 29, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CN (2)