Clinical Trials List
Protocol NumberNGM707-IO-101
NCT Number(ClinicalTrials.gov Identfier)NCT04913337
Completed
2022-01-05 - 2026-01-06
Phase I/II
Recruiting4
A Phase 1/2 Dose Escalation/Expansion Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- HUAI-CHENG HUANG Division of Hematology & Oncology
- Chia-Chi Lin Division of Hematology & Oncology
- TA-CHEN HUANG Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- Kun-Huei Yeh Division of Hematology & Oncology
- JHE-CYUAN GUO Division of Hematology & Oncology
- Yu-Chieh Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- TSU-YI CHAO 無
- 莊博雅 無
- Yao-Yu Hsieh 無
- HUI-WEN LIU 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ching Yun Hsieh Division of Hematology & Oncology
- 連銘瑜 Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Jui Yen
Co-Principal Investigator
- 顏志傑 Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Mesothelioma
Objectives
Parts 1a, 1b, and 1c
Primary Objectives:
Part 1a
• Evaluate the safety and tolerability of NGM707 dose tiers in consecutive patients with advanced solid tumors, based on all available clinical data from the Phase 1 trial, and describe the dosing regimen for the expanded cohort.
Part 1b
• Evaluate the safety and tolerability of NGM707 combined with pembrolizumab to achieve MAD/MTD, based on all available clinical data from the Phase 1 trial, to describe the combination dosing regimen for the expanded cohort.
Part 1c
• Evaluate the safety and tolerability of NGM707 combined with pembrolizumab to achieve MAD/MTD, to select an expanded dosing regimen for HCC patients.
Secondary Objectives:
Part 1a
• Investigate the pharmacokinetic (PK) characteristics of NGM707 after IV dosing.
• Evaluate the immunogenicity of NGM707 after monotherapy.
Parts 1b and 1c
• Investigate IV dosing. PK Characteristics of NGM707 after Dosing and Combination with Pembrolizumab
• Assess the immunogenicity of NGM707
Exploratory Objectives:
• Assess the preliminary antitumor activity of NGM707 as monotherapy and in combination with pembrolizumab
• May assess the correlation between biomarkers and clinical treatment outcomes (toxicity, efficacy, PK)
• Assess pembrolizumab drug concentration data after patient dosing
• Assess the immunogenicity of pembrolizumab
Parts 2a and 2b
Primary Objectives:
Part 2a
• Assess the antitumor activity of NGM707 as monotherapy
• Assess the safety and tolerability of NGM707 as monotherapy
Part 2b
• Assess the antitumor activity of NGM707 in combination with pembrolizumab
• Assess the safety and tolerability of NGM707 in combination with pembrolizumab
Secondary Objectives:
Parts 2a and 2b Part 1
• Assess NGM707 drug concentration data after patient administration
• Assess the immunogenicity of NGM707
• Assess the immunogenicity of NGM707 in combination with pembrolizumab
Exploratory Goals
Parts 2a and 2b
• May assess the correlation between biomarkers and clinical treatment outcomes (toxicity, efficacy, PK)
Part 2b
• Assess pembrolizumab drug concentration data after patient administration
• Assess the immunogenicity of pembrolizumab
Test Drug
靜脈輸注液
Active Ingredient
NGM707
Dosage Form
246
Dosage
20 mg/mL , 60 mg/mL
Endpoints
Parts 1a, 1b, and 1c
• DLT
• Treatment-related adverse events (AEs): Classification includes type, frequency, severity (according to NCI CTCAE version 5.0), time of occurrence, severity, and relationship to the investigational drug.
Parts 2a and 2b
• Treatment-related AEs: Classification includes type, frequency, severity (according to NCI CTCAE version 5.0), time of occurrence, severity, and relationship to the investigational drug.
• Objective tumor response (ORR) as defined in RECIST version 1.1
• DLT
• Treatment-related adverse events (AEs): Classification includes type, frequency, severity (according to NCI CTCAE version 5.0), time of occurrence, severity, and relationship to the investigational drug.
Parts 2a and 2b
• Treatment-related AEs: Classification includes type, frequency, severity (according to NCI CTCAE version 5.0), time of occurrence, severity, and relationship to the investigational drug.
• Objective tumor response (ORR) as defined in RECIST version 1.1
Inclution Criteria
Inclusion Criteria:
Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.
Adequate bone marrow, kidney and liver function.
Performance status of 0 or 1.
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.
Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.
Adequate bone marrow, kidney and liver function.
Performance status of 0 or 1.
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.
Exclusion Criteria
Exclusion Criteria:
Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
The Estimated Number of Participants
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Taiwan
45 participants
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Global
382 participants
