Period 1:

100 mg oral dose of IMP4297 (5 capsules, 20 mg/capsule);

Period 2:

100 mg oral dose of IMP4297 (10 capsules, 10 mg/capsule);

Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each Dose.

Period 1:

100 mg oral dose of IMP4297 (10 capsules, 10 mg/capsule);

Period 2:

100 mg oral dose of IMP4297 (5 capsules, 20 mg/capsule);

Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each Dose.

IMP4297 10mg/capsule; IMP4297 20mg/capsule;

IMP4297

An open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (20 mg capsules and 10 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects

This will be an open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (10 mg capsules and 20 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects. It will be conducted at one site, and approximately a total of 18 subjects will be enrolled.

Subjects will be randomized to one of the 2 treatment sequences according to a computer-generated randomization schedule. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each period.

BA Study of IMP4297 (20mg vs 10mg) in Healthy Male Subjects

An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Compare the Bioavailability of Two IMP4297 Formulations (20 mg Capsules and 10 mg Capsules) After Single Oral Administration of 100 mg IMP4297 Under Fasted Condition in Healthy Male Subjects

area under the curve from time zero to the time with the last quantifiable concentration

area under the curve from time zero to infinity

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Impact Therapeutics, Inc.

Period 1: Fasted control → Period 2: Fed control

Period 1: Fed control → Period 2: Fasted control

A phase I, single-site, open-label, randomized, single-dose, two-way crossover study to evaluate the effect of food on the pharmacokinetic characteristics of IMP4297 capsules in China

This food-effect study plans to enroll 16 (at least 12 to complete the study) subjects. Subjects will be randomly assigned to 1 of 2 dosing sequences (fasted or standard high-fat breakfast) at a 1:1 ratio generated from a computer. Each dosing sequence will consist of 2 cycles, with 1 dose in each cycle of the study and a washout period of at least 7 days between each dose. Study drug will be administered to subjects in the morning of each administration day of each cycle. PK, ECG, vital signs, physical examinations and laboratory tests will be performed as specified in the protocol. Tolerability and safety of the treatment will be evaluated by monitoring adverse events.

IMP4297 Food Effect Trial in Healthy Volunteers

An Open-label, Randomized, Single-dose, Two-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of IMP4297 Capsules in Healthy Subjects

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Calvin mei

Xiaohua Wu

A phase II, multi-center, open-label, single-arm, non-randomized study to evaluate the efficacy, safety and tolerability of IMP4297 capsules in subjects with germline and/or systemic BRCA1/2 mutated advanced ovarian cancer in china

A total of 100 subjects with germline and/or systemic BRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety, tolerability and PK profile of IMP4297.

The primary objective is to assess ORR in subjects with germline and/or systemic BRCA1/2 mutated advanced ovarian cancer with at least 2 prior lines of standard systemic therapy treated with IMP4297 capsules by independent imaging according to RECIST v1.1. Subjects will be treated until there is evidence of disease progression or any other discontinuation criterion is met. Best supportive care will be provided to all subjects and will be decided by investigators if there are no other specific restrictions within the protocol.

Four to seven blood samples (approximately 2 mL/sample) are planned to be collected for each enrolled subject for the popPK and/or dose-response evaluation. Sample collection visits are planned on Cycle (C) 1 Day (D) 1, C1D15, C2D1, C3D1 and C4D1. The actual administration time, dose and blood collection time should be accurately recorded.

2) Female subjects ≥ 18 years of age with histologically or cytologically confirmed advanced non-mucinous ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer

Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer

A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of IMP4297 Capsules in Subjects With Germline and/or Systemic BRCA1/2 Mutation Positive Advanced Ovarian Cancer With at Least 2 Prior Lines of Standard Systemic Therapy

Disease response as determined by Overall Response Rate per RECIST Version 1.1

Disease response as determined by Duration of Response per RECIST Version 1.1

Disease response as determined by Progression Free Survival per RECIST Version 1.1

Disease response as determined by Disease Control Rate per RECIST Version 1.1

Disease response as determined by Clinical Benefit Rate per RECIST Version 1.1

Disease response as determined by overall survival

Treatment-Emergent Adverse Events assessed by the investigator according to CTCAE 4.03

Skin and Connective Tissue Diseases

Breast Neoplasms

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

The dose levels will be escalated following a modified 3+3 dose escalation scheme.

BingHe Xu, Doctor

JunNing Cao, Doctor

This is a Phase I, first-in-human, open-label, dose-escalation study of IMP4297 administered orally once every day to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Patients with advanced breast cancer, ovarian cancer or prostate cancer are preferred. There are two stages to this study: a dose-escalation stage and a dose-expansion stage.

A Study of IMP4297 in Patients With Advanced Solid Tumors

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors

Evaluate the TEAE (treatment-emergent adverse event) of IMP4297

Spots Global Cancer Trial Database for imp4297

Every month we try and update this database with for imp4297 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BA Study of IMP4297 (20mg vs 10mg) in Healthy Male Subjects	NCT04351165	Solid Tumor	IMP4297	18 Years - 55 Years	Impact Therapeutics, Inc.
IMP4297 Food Effect Trial in Healthy Volunteers	NCT04057729	Solid Tumor	IMP4297	18 Years - 55 Years	Impact Therapeutics, Inc.
Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer	NCT04089189	Ovarian Cancer	IMP4297	18 Years -	Impact Therapeutics, Inc.
A Study of IMP4297 in Patients With Advanced Solid Tumors	NCT03508011	Advanced Solid ... Breast Cancer Ovarian Cancer Prostate Cancer	IMP4297	18 Years - 70 Years	Impact Therapeutics, Inc.
Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer	NCT04089189	Ovarian Cancer	IMP4297	18 Years -	Impact Therapeutics, Inc.
IMP4297 Food Effect Trial in Healthy Volunteers	NCT04057729	Solid Tumor	IMP4297	18 Years - 55 Years	Impact Therapeutics, Inc.

Spots Global Cancer Trial Database for imp4297

Every month we try and update this database with for imp4297 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imp4297 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.