Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily join this study, sign the informed consent form, and have good compliance;

Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months;

Histologically or cytologically diagnosed with advanced cancers;

Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;

Disqualifiers

Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;

Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;

Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;

Long-term unhealed wounds or fractures

Trial design

Design model

Single group

Treatments tested in this trial

  • TQB2922 for injection

    Drug

    TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: TQB2922 for injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity (DLT)

DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred.

Time frame
During the first treatment cycle (28 days).
2

Maximum tolerated dose (MTD)

MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

Time frame
During the first treatment cycle (28 days).
3

Adverse events (AEs) rate

The occurrence rate of all AEs during treatment

Time frame
From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
4

Adverse events (AEs) severity

The severity of all AEs occured during treatment

Time frame
From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.

Secondary outcomes

1

Half-life (T1/2)

Terminal half-life (T1/2) after administration

Time frame
Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
2

The area under the curve (AUC)

The area under the curve (AUC) of blood concentration-time of TQB2922.

Time frame
Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
3

Apparent plasma clearance (CL)

Apparent plasma clearance of TQB2922.

Time frame
Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
4

Apparent volume of distribution (Vz)

The ratio of the amount of TQB2922 in the body to the blood concentration

Time frame
Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

Other outcomes

Sponsors and contacts

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