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A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

RecruitingPhase 1, Phase 2Ages any - anyAllJacobio Pharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification). 2. Able to provide an archived tumor tissue sample or fresh biopsy sample. 3. Life expectancy โ‰ฅ3 months at the start of treatment. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. โ‰ฅ1 measurable lesion per RECIST v1.1. 6. Adequate organ function. Exclusion Criteria: 1. Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication. 2. Previous treatment with rat sarcoma (RAS) targeting agents. 3. Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases. 4. Impaired cardiovascular function or clinically significant cardiac disease. 5. Mean QT interval corrected using Fridericia's formula (QTcF) \>470 msec. 6. Females who are pregnant or breastfeeding.
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What it tests

  • JAB-23E73
  • JAB-23E73
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Where

32 sites
Anhui Provincial Cancer Hospital
Hefei, China
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Fujian cancer Hospital
Fuzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China

โ€ฆand 24 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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