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Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor

ConditionsSolid TumorsNeoplasms (Cancer / Tumors)Advanced Malignant Solid NeoplasmLocally Advanced Malignant Solid NeoplasmUnresectable Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmHER2 ExpressionBiliary Tract NeoplasmsEndometrial NeoplasmsUrothelial Carcinoma (UC)Pancreatic NeoplasmsColorectal NeoplasmsGastric NeoplasmsNon-Small Cell Lung Carcinoma (NSCLC)Head and Neck NeoplasmsCervical Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaihua Yuan

About this trial

The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.

The main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg/kg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants aged 18 years or older.

Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced/metastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.

Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).

Disqualifiers

Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L).

Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association [NYHA] classification).

Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.

History of active tuberculosis.

Trial design

Design model

Single group

Treatments tested in this trial

  • Trastuzumab Rezetecan

    Drug

    Trastuzumab Rezetecan will be administered on Day 1 of each 21-day cycle as specified. The dose is 4.8 mg/kg (fixed 408 mg for body weight ≥85 kg). Treatment continues until tumor progression or occurrence of unacceptable toxicity.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Trastuzumab RezetecanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate, ORR

The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Time frame
From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.

Secondary outcomes

1

Duration of Response, DOR

Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.

Time frame
From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first, assessed up to 24months.
2

Progression-Free Survival, PFS

Progression-Free Survival (PFS) is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1.

Time frame
Through study completion, an average of 2 years.
3

Overall Survival, OS

Overall Survival (OS) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.

Time frame
Through study completion, an average of 2 years.
4

Disease Control Rate, DCR

Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or SD maintained more than 8 weeks. Tumor responses were assessed by investigators using RECIST version 1.1.

Time frame
From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Haihua Yuan

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: