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Trial Title:
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
NCT ID:
NCT06386146
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JAB-30355
Description:
Oral administration
Arm group label:
Dose escalation phase
Intervention type:
Drug
Intervention name:
JAB-30355
Description:
Oral administration
Arm group label:
Dose expansion phase
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research site
Address:
City:
Lake Mary
Zip:
32771
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research site
Address:
City:
Rochester
Zip:
55906
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research site
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Research site
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Facility:
Name:
Research site
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Start date:
July 24, 2024
Completion date:
July 2027
Lead sponsor:
Agency:
Jacobio Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Jacobio Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06386146
