A First-in-Human JAB-8263 in Adult Patients With Advanced Tumors
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- STATUS
- Recruiting
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- days left to enroll
- 26
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- participants needed
- 152
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- sponsor
- Jacobio Pharmaceuticals Co., Ltd.
Summary
This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study.
These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.
Description
JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.
The objectives of this study are:
To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced malignant tumors. To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc).To evaluate preliminary antitumor activity of JAB-8263
Details
| Condition | nsclc, Cancer, malignant tumors, Squamous Cell Carcinoma of Esophagus, malignant tumor, small cell carcinoma, ovarian carcinomas, malignancies, ovarian epithelial carcinoma, Non-Small Cell Lung Cancer, carcinoma of the ovary, Mycosis Fungoides, Acute myeloid leukemia, Cancer/Tumors, Oat cell carcinoma, ovarian carcinoma, Ovarian Cancer, anll, Esophageal Squamous Cell Carcinoma, Neoplasms, malignancy, Comoros, Castration-Resistant Prostate Cancer, Ewing's Family Tumors, cancer of the ovary, Castration-Resistant Prostate Carcinoma, CRPC, Acute Myeloid Leukemia, cancer ovarian, small cell carcinoma of the lung, Recurrent Ovarian Cancer, Epithelial Ovarian Carcinoma, acute myelogenous leukemia, Acute Myelogenous Leukemia (AML), sclc, Small Cell Lung Cancer, Cancer (Pediatric), small cell carcinomas, cancers, cancer, ovarian, acute myeloblastic leukemia |
|---|---|
| Treatment | JAB-8263 |
| Clinical Study Identifier | NCT04686682 |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. |
| Last Modified on | 3 August 2021 |
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