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A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma

ConditionGastroesophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

TQB2102 for injection is a novel antibody-coupled drug (ADC) that enhances binding to tumor cell surface HER2 proteins by simultaneously targeting the two non-overlapping epitopes of the HER2 protein, Endothelial Cell Dysfunction 2 (ECD2) and Endothelial Cell Dysfunction 4 (ECD4), increasing HER2 internalization, and then down-regulating the tumor cell surface HER2 proteins more effectively, and doubly blocking the HER2 signaling, to achieve the effects of trastuzumab and Pertuzumab alone and in combination. This is a Phase II study to evaluate the efficacy and safety of TQB2102 for injection in combination with Benmelstobart Injection /Penpulimab Injection ± chemotherapy in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy≥3 months;

Histopathologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma;

HER2 expression levels of Immunohistochemistry(IHC) 3+ or IHC 2+ and In Situ Hybridization (ISH) positivity were confirmed in tumor tissue;

Subject is able to provide previous compliant PD-L1 expression level test results or is able to provide sufficient and competent tumor tissue for PD-L1 expression level testing;

Disqualifiers

Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;

Uncontrollable toxic reactions above CTC AE grade 1 due to any prior therapy, excluding alopecia;

Major surgical treatment, incisional biopsy or significant traumatic injury or prolonged unhealed wound or fracture within 28 days prior to first dose;

Prior history of interstitial lung disease/pneumonia (non-infectious) requiring steroidal drug intervention or current concomitant (or suspected) interstitial lung disease/pneumonia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy

    Drug

    TQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody

  • TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy

    Drug

    TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody

  • TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy

    Drug

    TQB2102 for injection is an antibody-coupled drug

Treatment groups

204 Participants
are divided into 3 treatment groups
Group A: TQB2102 for injection (7.5 mg) +Benmelstobart+ChemotherapyExperimental treatment 1 intervention
Group B: TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+ChemotherapyExperimental treatment 1 intervention
Group C: TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+ChemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 and guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST )for solid tumors.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Progression-free survival (PFS)

Defined as the time from first use of TQB2102 to first disease progression or death from any cause

Time frame
Baseline up to disease progression or die, an average of 3 year
2

Duration of Response (DOR)

Defined as the time from first documented response to documented disease progression or death

Time frame
Through study completion, an average of 1 year
3

Overall survival(OS)

Overall survival refers to the time from the first treatment to death from any cause

Time frame
Baseline up to die, an average of 3 year
4

Number of patients with adverse events (AEs) and serious adverse events (SAEs)

Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
Baseline up to 28 days after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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