Clinical Trials List
Protocol NumberIMP4297-106
NCT Number(ClinicalTrials.gov Identfier)NCT04434482
2020-04-01 - 2024-03-15
Phase I/II
Recruiting4
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 Phase I, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
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Trial Applicant
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Sponsor
IMPACT Therapeutics Australia Pty Ltd and IMPACT Therapeutics Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- Chien-Ying Liu Division of General Internal Medicine
- Chih-Hsi Kuo Division of General Internal Medicine
- 枋岳甫 Division of General Internal Medicine
- Wen-Cheng Chang Division of General Internal Medicine
- 邱立忠 Division of General Internal Medicine
- 吳振德 Division of General Internal Medicine
- Cheng-Ta Yang Division of General Internal Medicine
- 柯皓文 Division of General Internal Medicine
- 吳教恩 Division of General Internal Medicine
- Chih-Hung Chen Division of General Internal Medicine
- 林定佑 Division of General Internal Medicine
- Chih-Liang Wang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jih-Hsiang Lee Division of Hematology & Oncology
- 廖唯昱 Division of General Internal Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 徐偉勛 Division of Hematology & Oncology
- Chong-Jen Yu Division of General Internal Medicine
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumorsand/ Small Cell Lung Cancer
Objectives
Primary Objectives
To evaluate the safety and tolerability of IMP4297 in combination with temozolomide
To determine the maximum tolerated dose (MTD) (if any) and select the recommended phase 2 dose (RP2D) of IMP4297 and temozolomide
Secondary Objectives
To characterize the plasma PK profile of IMP4297 and temozolomide via population PK (popPK) modeling
To evaluate the effect of IMP4297 on QT interval
To evaluate the preliminary anti-tumor activity of IMP4297 in combination with temozolomide
Test Drug
IMP4297 and Temozolomide
Active Ingredient
IMP4279
Temozolomide
Temozolomide
Dosage Form
capsule
capsule
capsule
Dosage
10
5
5
Endpoints
Primary Outcome Measures :
Safety endpoints [ Time Frame: 6 months ]
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
MTD [ Time Frame: Within 28 days after IMP4297 and temozolomide administrated ]
the maximum tolerated dose
RP2D [ Time Frame: Within 28 days after IMP4297 and temozolomide administrated ]
the recommended phase 2 dose
Secondary Outcome Measures :
plasma PK profile [ Time Frame: 6 months ]
To characterize the plasma PK profile of IMP4297 and temozolomide via population PK (popPK) modeling
anti-tumor activity [ Time Frame: 6 months ]
To evaluate the preliminary anti-tumor activity of IMP4297 in combination with temozolomide
Safety endpoints [ Time Frame: 6 months ]
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
MTD [ Time Frame: Within 28 days after IMP4297 and temozolomide administrated ]
the maximum tolerated dose
RP2D [ Time Frame: Within 28 days after IMP4297 and temozolomide administrated ]
the recommended phase 2 dose
Secondary Outcome Measures :
plasma PK profile [ Time Frame: 6 months ]
To characterize the plasma PK profile of IMP4297 and temozolomide via population PK (popPK) modeling
anti-tumor activity [ Time Frame: 6 months ]
To evaluate the preliminary anti-tumor activity of IMP4297 in combination with temozolomide
Inclution Criteria
Inclusion Criteria:
The patient must voluntarily participate in this clinical study and be willing and able to provide written informed consent/assent for the trial.
18 to 75 years of age (18 and 75 included) on the day of signing informed consent form (ICF), males or females.
Patient population:
In Part I: The patient must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment exists.
In Part II: The patients must be histologically or cytologically confirmed ES-SCLC with disease progression after the 1L standard platinum-based therapy.
Patients have an ECOG performance status of 0 to 1.
Patients have a life expectancy of ≥12 weeks.
In Part II: patients have at least 1 measurable lesion per RECIST v1.1.
Patients have adequate organ function, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 28 days before the administration of the IPs).
Female patients should meet at least 1 of the following criteria before they can participate in the study:
Females who have no childbearing potential (i.e., physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
Post-menopausal (total cessation of menses for ≥1 year).
For those with childbearing potential, they should have a negative serum pregnancy test during the screening period (within 7 days prior to the first dose of the IPs), should not be in lactation, and willing to take effective contraceptive measures throughout the study period, from study entry up to 6 months after the last dose of the IP(s).
Male patients are eligible to participate in the study if they have undergone vasectomy or agree to use effective methods of contraception from study entry up to 6 months after the last dose of the IP(s).
The patient must voluntarily participate in this clinical study and be willing and able to provide written informed consent/assent for the trial.
18 to 75 years of age (18 and 75 included) on the day of signing informed consent form (ICF), males or females.
Patient population:
In Part I: The patient must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment exists.
In Part II: The patients must be histologically or cytologically confirmed ES-SCLC with disease progression after the 1L standard platinum-based therapy.
Patients have an ECOG performance status of 0 to 1.
Patients have a life expectancy of ≥12 weeks.
In Part II: patients have at least 1 measurable lesion per RECIST v1.1.
Patients have adequate organ function, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 28 days before the administration of the IPs).
Female patients should meet at least 1 of the following criteria before they can participate in the study:
Females who have no childbearing potential (i.e., physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
Post-menopausal (total cessation of menses for ≥1 year).
For those with childbearing potential, they should have a negative serum pregnancy test during the screening period (within 7 days prior to the first dose of the IPs), should not be in lactation, and willing to take effective contraceptive measures throughout the study period, from study entry up to 6 months after the last dose of the IP(s).
Male patients are eligible to participate in the study if they have undergone vasectomy or agree to use effective methods of contraception from study entry up to 6 months after the last dose of the IP(s).
Exclusion Criteria
Exclusion Criteria:
Patients with primary tumor in central nervous system (CNS) and active or untreated central CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with IPs.
Patients with serious acute and chronic infections.
Patients who have previously received PARP inhibitors.
Patients who have received a live-virus vaccination within 28 days of the planned start of study.
Patients who have participated a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of treatment.
Patients have not recovered (i.e., to ≤Grade 1 or to baseline, as evaluated by NCI-CTCAE v5.0) from cytotoxic therapy-induced AEs, except for alopecia.
Patients who have received chemotherapy, targeted therapy, endocrine therapy anti-tumor Chinese herbal medicine or proprietary Chinese medicine treatment, or other anti-cancer systemic treatment within 5 half-lives or 14 days, whichever is longer prior to the first dose of the IPs.
Patients who have undergone a major surgery within 28 days prior to the study treatment, or have undergone a radical radiotherapy, or have undergone a palliative radiotherapy within 14 days prior to the study treatment, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the study treatment.
Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently).
Patients with a history of seizures.
Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS).
Patients who have major cardiovascular diseases (such as congestive heart failure, unstable angina, atrial fibrillation, arrhythmia); patients who have acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to the first dose of the IPs; patients who have congestive heart failure (≥New York Heart Association [NYHA] Classification Class II); patients who have severe arrhythmia requiring medication (including QT interval [QTc] prolongation corrected by the Fridericia's formula [QTcF] of more than 480 msec, pacemaker installation, and previous diagnosis of congenital long QT syndrome).
Patients who are unable to swallow capsules. Patients have gastrointestinal illnesses that may affect the absorption of oral medication IMP4297 and temozolomide.
Patients with a known hypersensitivity to IMP4297, temozolomide or any of the excipients of the products.
Patients who have received transplantation including patients with previous allogeneic bone marrow transplant.
Patients known to have a history of alcoholism or drug abuse.
The investigator believes that the patient's underlying disease may put the patient at risk in IP administration or may affect the evaluation of toxicity events or AEs.
Patients with primary tumor in central nervous system (CNS) and active or untreated central CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with IPs.
Patients with serious acute and chronic infections.
Patients who have previously received PARP inhibitors.
Patients who have received a live-virus vaccination within 28 days of the planned start of study.
Patients who have participated a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of treatment.
Patients have not recovered (i.e., to ≤Grade 1 or to baseline, as evaluated by NCI-CTCAE v5.0) from cytotoxic therapy-induced AEs, except for alopecia.
Patients who have received chemotherapy, targeted therapy, endocrine therapy anti-tumor Chinese herbal medicine or proprietary Chinese medicine treatment, or other anti-cancer systemic treatment within 5 half-lives or 14 days, whichever is longer prior to the first dose of the IPs.
Patients who have undergone a major surgery within 28 days prior to the study treatment, or have undergone a radical radiotherapy, or have undergone a palliative radiotherapy within 14 days prior to the study treatment, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the study treatment.
Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently).
Patients with a history of seizures.
Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS).
Patients who have major cardiovascular diseases (such as congestive heart failure, unstable angina, atrial fibrillation, arrhythmia); patients who have acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to the first dose of the IPs; patients who have congestive heart failure (≥New York Heart Association [NYHA] Classification Class II); patients who have severe arrhythmia requiring medication (including QT interval [QTc] prolongation corrected by the Fridericia's formula [QTcF] of more than 480 msec, pacemaker installation, and previous diagnosis of congenital long QT syndrome).
Patients who are unable to swallow capsules. Patients have gastrointestinal illnesses that may affect the absorption of oral medication IMP4297 and temozolomide.
Patients with a known hypersensitivity to IMP4297, temozolomide or any of the excipients of the products.
Patients who have received transplantation including patients with previous allogeneic bone marrow transplant.
Patients known to have a history of alcoholism or drug abuse.
The investigator believes that the patient's underlying disease may put the patient at risk in IP administration or may affect the evaluation of toxicity events or AEs.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
65 participants
