Clinical Trials List
Protocol NumberF60089IV101
Active
2024-10-01 - 2032-12-31
Phase I
Recruiting3
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A First-In-Human (FIH) phase I/II open-label, multicentre, dose escalation and expansion trial of VERT-002 in patients with locally advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) harboring MET alterations.
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Sponsor
PIERRE FABRE MEDICAMENT
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Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
- 吳宗哲 Division of Thoracic Medicine
- James Chih-Hsin Yang Division of Thoracic Medicine
- 蔡子修 Division of Thoracic Medicine
- Chong-Jen Yu Division of Thoracic Medicine
- YEN-TING LIN Division of Thoracic Medicine
- 許嘉林 Division of Thoracic Medicine
- 廖斌志 Division of Thoracic Medicine
- 吳尚俊 Division of Thoracic Medicine
- JIN-YUAN SHIH Division of Thoracic Medicine
- 楊景堯 Division of Thoracic Medicine
- CHAO-CHI HO CHAO-CHI HO Division of Thoracic Medicine
- Jih-Hsiang Lee Division of Thoracic Medicine
- 徐偉勛 Division of Thoracic Medicine
- 廖唯昱 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
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
To characterize the overall safety and
tolerability of VERT-002
Test Drug
injection
Active Ingredient
VERT-002
Dosage Form
27D
Dosage
50mg/mL
Endpoints
✓ Safety: Incidence and severity of Treatment Emergent Adverse Events
(TEAEs)/Treatment Emergent Serious Adverse Events (TESAEs) including
changes in laboratory values, physical examination, Eastern Cooperative
Oncology Group (ECOG) performance status, vital signs and
electrocardiogram (ECG) according to National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria
(NCI 2017).
✓ Tolerability: TEAEs/TESAEs leading to VERT-002 dose reductions,
interruptions, and discontinuations.
(TEAEs)/Treatment Emergent Serious Adverse Events (TESAEs) including
changes in laboratory values, physical examination, Eastern Cooperative
Oncology Group (ECOG) performance status, vital signs and
electrocardiogram (ECG) according to National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria
(NCI 2017).
✓ Tolerability: TEAEs/TESAEs leading to VERT-002 dose reductions,
interruptions, and discontinuations.
Inclution Criteria
Screening (for all parts unless otherwise specified)
1. Signed and dated informed consent for participation in the trial obtained according to ICH GCP, and
national/local regulations.
2. Male or female ≥ 18 years of age at the time of signing informed consent, but at least of legal age in their
country.
3. Part 1: histological confirmation of relapsed and/or refractory locally advanced or metastatic solid tumor for
which no standard of care treatment is available.
4. Parts 2: histological confirmation of locally advanced or metastatic NSCLC Stage IIIB/C or IV (American
Joint Commission on Cancer [AJCC] 8th edition) in participants who are not eligible for or should have
received available standard of care therapies, including curative intent surgery, chemoradiation, radiotherapy
or systemic therapy.
5. Part 1: presence of at least one of the following MET alterations based on local documentation of blood or
archived tissue results:
- METex14 mutation.
- MET kinase domain activating gene mutations (e.g. H1094L/R/Y, D1228H/N/V, Y1230A/C/D/H).
- MET amplification.
MET amplification positivity criteria are defined by either method as follows:
- Gene Copy Number (GCN) ≥ 5 or MET to CEP7 (centromere of chromosome 7) ratio ≥ 2 (FISH)
- GCN ≥ 5 (NGS)
6. Part 2-a: presence of METex14 mutation (based on local documentation of blood or archived tissue results)
and for Part 2-b of at least one of the following MET alterations: METex14 mutation (based on local
documentation of blood or archived tissue results), de novo MET amplification (based on local documentation
of archived tissue results). Confirmation after enrollment in the trial will be performed by central testing from
an archival tumor biopsy (either tissue block or at least 15 serial cut unstained slides of 5 µm, at least 20%
tumor content). In case no archival biopsy is available for central testing, the participant must be willing to
have a fresh tumor biopsy sample collected and the tumor biopsy should be deemed safe and feasible by the
investigator.
MET amplification positivity criteria are defined by either method as follows:
- GCN ≥ 5 or MET to CEP7 ratio ≥ 2 (FISH)
- GCN ≥ 5 (NGS)
1. Signed and dated informed consent for participation in the trial obtained according to ICH GCP, and
national/local regulations.
2. Male or female ≥ 18 years of age at the time of signing informed consent, but at least of legal age in their
country.
3. Part 1: histological confirmation of relapsed and/or refractory locally advanced or metastatic solid tumor for
which no standard of care treatment is available.
4. Parts 2: histological confirmation of locally advanced or metastatic NSCLC Stage IIIB/C or IV (American
Joint Commission on Cancer [AJCC] 8th edition) in participants who are not eligible for or should have
received available standard of care therapies, including curative intent surgery, chemoradiation, radiotherapy
or systemic therapy.
5. Part 1: presence of at least one of the following MET alterations based on local documentation of blood or
archived tissue results:
- METex14 mutation.
- MET kinase domain activating gene mutations (e.g. H1094L/R/Y, D1228H/N/V, Y1230A/C/D/H).
- MET amplification.
MET amplification positivity criteria are defined by either method as follows:
- Gene Copy Number (GCN) ≥ 5 or MET to CEP7 (centromere of chromosome 7) ratio ≥ 2 (FISH)
- GCN ≥ 5 (NGS)
6. Part 2-a: presence of METex14 mutation (based on local documentation of blood or archived tissue results)
and for Part 2-b of at least one of the following MET alterations: METex14 mutation (based on local
documentation of blood or archived tissue results), de novo MET amplification (based on local documentation
of archived tissue results). Confirmation after enrollment in the trial will be performed by central testing from
an archival tumor biopsy (either tissue block or at least 15 serial cut unstained slides of 5 µm, at least 20%
tumor content). In case no archival biopsy is available for central testing, the participant must be willing to
have a fresh tumor biopsy sample collected and the tumor biopsy should be deemed safe and feasible by the
investigator.
MET amplification positivity criteria are defined by either method as follows:
- GCN ≥ 5 or MET to CEP7 ratio ≥ 2 (FISH)
- GCN ≥ 5 (NGS)
Exclusion Criteria
1. Parts 2: Documented evidence by local testing of targetable oncogene driver mutations including MET
fusion, KRAS, EGFR, ALK, ROS1.
2. History of a primary malignancy other than the cancer under trial (as defined for Parts 1 and 2) with the
exception of:
- Participants with a previous malignancy who completed their anticancer treatment at least 2 years
before signing informed consent and with no evidence of residual disease from the prior malignancy
at screening.
- Malignancies with a negligible risk of metastasis or death (i.e. 5-year overall survival rate > 90%)
that are adequately treated. Examples include, but are not limited to, completely resected basal cell
carcinoma and squamous cell carcinoma of skin, curatively treated in situ skin melanoma, curatively
treated prostate cancer, breast cancer and early gastric cancer cured by endoscopic mucosal resection
or endoscopic submucosal dissection.
3. Uncontrolled Central Nervous System (CNS) metastases or spinal cord compression that are associated with
progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease.
If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for
2 weeks prior to enrollment in the trial.
4. History of hypersensitivity to active or inactive ingredients of VERT-002, or drugs with a similar chemical
structure or from a similar class.
5. Active, bacterial, fungal, or viral infection, including, but not limited to: HBV, HCV, and known HIV or
AIDS-related illness, tuberculosis or an infection requiring systemic treatment within 2 weeks prior to the
first dose of VERT-002 (C1D1).
6. Positive Severe Acute Respiratory syndrome Coronavirus 2 (SARs-CoV-2) or variants of SARs-CoV2 test
within 2 weeks prior to first dose administration of VERT-002 (C1D1) or with suspected infection with
SARs-CoV-2 or variants of SARs-CoV-2 and confirmation pending.
fusion, KRAS, EGFR, ALK, ROS1.
2. History of a primary malignancy other than the cancer under trial (as defined for Parts 1 and 2) with the
exception of:
- Participants with a previous malignancy who completed their anticancer treatment at least 2 years
before signing informed consent and with no evidence of residual disease from the prior malignancy
at screening.
- Malignancies with a negligible risk of metastasis or death (i.e. 5-year overall survival rate > 90%)
that are adequately treated. Examples include, but are not limited to, completely resected basal cell
carcinoma and squamous cell carcinoma of skin, curatively treated in situ skin melanoma, curatively
treated prostate cancer, breast cancer and early gastric cancer cured by endoscopic mucosal resection
or endoscopic submucosal dissection.
3. Uncontrolled Central Nervous System (CNS) metastases or spinal cord compression that are associated with
progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease.
If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for
2 weeks prior to enrollment in the trial.
4. History of hypersensitivity to active or inactive ingredients of VERT-002, or drugs with a similar chemical
structure or from a similar class.
5. Active, bacterial, fungal, or viral infection, including, but not limited to: HBV, HCV, and known HIV or
AIDS-related illness, tuberculosis or an infection requiring systemic treatment within 2 weeks prior to the
first dose of VERT-002 (C1D1).
6. Positive Severe Acute Respiratory syndrome Coronavirus 2 (SARs-CoV-2) or variants of SARs-CoV2 test
within 2 weeks prior to first dose administration of VERT-002 (C1D1) or with suspected infection with
SARs-CoV-2 or variants of SARs-CoV-2 and confirmation pending.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
158 participants
