NCT06386146 JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
| NCT ID | NCT06386146 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-07-24 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 144 participants in total. It began in 2024-07-24 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06386146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06386146 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06386146 currently recruiting?
Yes, NCT06386146 is actively recruiting participants. Contact the research team at clinicaltrials@jacobiopharma.com for enrollment information.
Where is the NCT06386146 trial being conducted?
This trial is being conducted at Denver, United States, Lake Mary, United States, St Louis, United States, Canton, United States and 11 additional locations.
Who is sponsoring the NCT06386146 clinical trial?
NCT06386146 is sponsored by Jacobio Pharmaceuticals Co., Ltd.. The trial plans to enroll 144 participants.