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Clinical Trials List

Protocol NumberGCT1042-01
NCT Number(ClinicalTrials.gov Identfier)NCT04083599

2023-04-01 - 2025-12-31

Phase I/II

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

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei 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 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 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 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 Chun-Hui Lee Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Malignant Solid Tumor

Objectives

main For the dose escalation and safety lead-in section: ‧ Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 alone or in combination with pembrolizumab with or without concomitant chemotherapy For dose expansion as monotherapy and combination therapy: ‧ To evaluate the anti-tumor activity of GEN1042 alone and in combination with pembrolizumab with or without concomitant chemotherapy secondary ‧ To assess the safety and tolerability of GEN1042 alone and in combination with pembrolizumab with or without concomitant chemotherapy ‧ To evaluate the anti-tumor activity of GEN1042 alone and in combination with pembrolizumab with or without concomitant chemotherapy ‧ To study the pharmacokinetic (PK) and immunogenicity characteristics of GEN1042 administered alone or in combination with pembrolizumab with or without concomitant chemotherapy exploratory ‧ Evaluate potential pharmacodynamics/safety biomarkers of GEN1042 when administered as monotherapy or in combination therapy ‧ Evaluate potential biomarkers that predict clinical response when GEN1042 is administered as monotherapy or in combination therapy ‧ Evaluate the anti-tumor activity of GEN1042 when administered as monotherapy or in combination according to the Immune Response Evaluation Criteria in Solid Tumors (iRECIST)

Test Drug

Gen1042

Active Ingredient

GEN1042

Dosage Form

Solution

Dosage

10mg/ml

Endpoints

For the dose escalation and safety lead-in section:
‧ Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 alone or in combination with pembrolizumab with or without concomitant chemotherapy
For dose expansion as monotherapy and combination therapy:
‧ To evaluate the anti-tumor activity of GEN1042 alone and in combination with pembrolizumab with or without concomitant chemotherapy

Inclution Criteria

Key Inclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
Subjects with a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy
Combination Therapy - Dose Expansion Part

Subjects with unresectable Stage III or Stage IV melanoma with no prior systemic anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal melanoma is excluded.
Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation.
Subjects with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting.
Subjects with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
General (all phases):

Must be age ≥ 18 years of age on the day of signing informed consent, or the legal age of consent in the jurisdiction in which the trial is taking place.
Measurable disease according to RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) 0-1
Normal or adequate liver, renal, cardiac and bone marrow function

Exclusion Criteria

Key Exclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration
Radiotherapy within 14 days prior to first GEN1042 administration
Toxicities from previous anti-cancer therapies that have not resolved
Combination Therapy - Dose Expansion Part

Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of the first dose of trial treatment.
Radiotherapy within 14 days of start of trial treatment or received lung radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.
General (all phases)

Subject has an active, known, or suspected autoimmune disease.
History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
Subject with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    1287 participants

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