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Clinical Trials List

Protocol NumberGCT1184-05
NCT Number(ClinicalTrials.gov Identfier)NCT07288177
Not yet recruiting

2026-02-26 - 2028-04-30

Phase II

Not yet recruiting1

Recruiting7

A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 高婉真

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer (NSCLC)

Objectives

主要目標 : 評估 Rina-S 單一療法的抗腫瘤活性

Test Drug

注射用凍晶粉末

Active Ingredient

Rinatabart Sesutecan (Rina-S, GEN1184)

Dosage Form

048

Dosage

Amount 1

Endpoints

主要評估指標 : 由試驗主持人依據實體腫瘤療效反應評估標準 (RECIST) 第1.1 版評估的客觀反應率 (ORR)

Inclution Criteria

Key Inclusion Criteria:

Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
Participant must have radiological disease progression while on or after receiving the most recent regimen.
Participants either may have actionable genetic alterations (AGAs) or no AGAs.
Participant has measurable disease according to RECIST v1.1.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.

Exclusion Criteria

Key Exclusion Criteria (all study cohorts):

Participant has NSCLC with histology other than adenocarcinoma
Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.

The Estimated Number of Participants

  • Taiwan

    6 participants

  • Global

    240 participants