Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

About this trial

This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily joined this study, signed the informed consent form, and had good compliance;

18-75 yeas old;

Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;

Expected survival of more than 12 weeks;

Disqualifiers

Current concomitant presence of other malignancies within 5 years prior to the first dose;

At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.

Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.

Hyperactive or venous thrombosis events occurred within 6 months before the first administration;

Trial design

Design model

Single group

Treatments tested in this trial

  • TQB2922 injection (subcutaneous injection)

    Drug

    TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: TQB2922 injection (subcutaneous injection)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to Peak Concentration

Time to Peak Concentration

Time frame
Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
2

Peak concentration

Maximum plasma drug concentration

Time frame
Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
3

half-life (T1/2)

Terminal half-life (T1/2)

Time frame
Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
4

The area under the curve (AUC0-∞)

The area under the plasma concentration-time curve extrapolated from the first administration to infinity

Time frame
Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

Secondary outcomes

1

Adverse Events (AE) rate

The occurrence and severity of all AEs

Time frame
From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first
2

Objective Response Rate (ORR)

Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria

Time frame
Up to 2 years
3

Duration of Response (DOR)

Defined as the time from first documented response to documented disease progression.

Time frame
Up to 3 years
4

Progression-free survival (PFS)

Defined as the time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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