JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386146
• Other study ID #: JAB-30355-1001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 781-918-6670
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: July 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• JAB-30355
Oral administration
• JAB-30355
Oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)	Number and proportion of participants who experience at least one dose limiting toxicity (DLT)	Approximately one year
Primary	Number of participants with adverse events	All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.	Approximately three years
Secondary	Peak Plasma Concentration (Cmax)	Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.	Approximately three years
Secondary	Time to reach the observed maximum (peak) concentration (Tmax)	Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.	Approximately three years
Secondary	Terminal half-life (t1/2)	Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.	Approximately three years
Secondary	Objective response rate (ORR)	ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Approximately three years
Secondary	Duration of response (DOR)	DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1.	Approximately three years