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Protocol NumberGCT1042-01
Active

2023-04-01 - 2026-08-30

Phase I

Recruiting7

ICD-10C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

ICD-10C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

ICD-10C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.8

Malignant neoplasm of other parts of bronchus or lung

A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

  • Trial Applicant

    Syneos Health

  • Sponsor

    Genmab

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/03/01

Investigators and Locations

Principal Investigator Chun-Hui Lee Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 簡志彥 Division of Otolaryngology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Muh-Hwa Yang Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Ming Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Ching Wang Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Malignant Solid Tumors

Objectives

Primary For dose escalation and safety run-in: • To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 administered alone or in combination with pembrolizumab with or without chemotherapy

Test Drug

liquid

Active Ingredient

GEN1042

Dosage Form

18A

Dosage

100 mg

Endpoints

For dose escalation and safety run-in:
• Dose-limiting toxicity

Inclution Criteria

Monotherapy
Subjects must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the
trial is taking place) on the day of signing informed consent; have measurable disease according
to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score
of 0-1; adequate organ, bone marrow, liver, coagulation, and renal function. For monotherapy
dose escalation only, subjects must have histologically or cytologically confirmed non-CNS
solid tumor that is metastatic or unresectable and for whom there is no available standard therapy
or subjects who are not candidates for such available therapy.

Exclusion Criteria

Monotherapy
Subjects must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the
trial is taking place) on the day of signing informed consent; have measurable disease according
to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score
of 0-1; adequate organ, bone marrow, liver, coagulation, and renal function. For monotherapy
dose escalation only, subjects must have histologically or cytologically confirmed non-CNS
solid tumor that is metastatic or unresectable and for whom there is no available standard therapy
or subjects who are not candidates for such available therapy.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    1287 participants

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