Clinical trial NCT06386146: JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: Approximately one year
measure: Number of participants with adverse events
timeFrame: Approximately three years
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: Approximately three years
measure: Time to reach the observed maximum (peak) concentration (Tmax)
timeFrame: Approximately three years
measure: Terminal half-life (t1/2)
timeFrame: Approximately three years
measure: Objective response rate (ORR)
timeFrame: Approximately three years
measure: Duration of response (DOR)
timeFrame: Approximately three years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Lake Mary
country: United States
facility: Research site
state: Florida
city: Saint Louis
country: United States
facility: Research site
state: Missouri
city: Canton
country: United States
facility: Research site
state: Ohio
city: Cleveland
country: United States
facility: Research site
state: Ohio
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research site
state: Texas
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
Study officials:
References: