JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JAB-30355, JAB-30355.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
Overview
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
Detailed description
This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.
Interventions
- Drug JAB-30355
Oral administration - Drug JAB-30355
Oral administration
Primary outcome measures
- Dose limiting toxicity (DLT) [Time frame: Approximately one year]
- Number of participants with adverse events [Time frame: Approximately three years]
Secondary outcome measures (5)
- Peak Plasma Concentration (Cmax) [Time frame: Approximately three years]
- Time to reach the observed maximum (peak) concentration (Tmax) [Time frame: Approximately three years]
- Terminal half-life (t1/2) [Time frame: Approximately three years]
- Objective response rate (ORR) [Time frame: Approximately three years]
- Duration of response (DOR) [Time frame: Approximately three years]
Eligibility criteria
Inclusion criteria
- Written informed consent.
- Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
- ECOG performance status score of 0 or 1.
- Has been treated with at least one line of systemic therapy for that tumor type and stage.
- Have documentation of confirmed TP53 Y220C mutation.
- At least 1 measurable lesion per RECIST v1.1.
- Adequate hematological, renal and hepatic function and appropriate coagulation condition.
- Able to swallow and retain orally administered medication.
Exclusion criteria
- Active brain or spinal metastases or primary CNS tumor.
- Active infection requiring systemic treatment within 7 days.
- Active HBV or HCV.
- Any severe and/or uncontrolled medical conditions.
- LVEF ≤50% assessed by ECHO or MUGA.
- QTcF > 470 msec.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 8 centers
- Research Site — Beijing
- Research Site — Beijing
- Research Site — Beijing
- Research Site — Guangzhou
- Research Site — Zhengzhou
- Research Site — Shenyang
- Research Site — Jinan
- Research Site — Shanghai
United States · 7 centers
- Research Site — Denver
- Research site — Lake Mary
- Research site — St Louis
- Research site — Canton
- Research site — Cleveland
- Research Site — Nashville
- Research site — Houston
Identifiers
NCT: NCT06386146 · JAB-30355-1001