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NCT06386146
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
Phase 1/Phase 2 trial testing JAB-30355 in Solid Tumors in 144 participants. Currently enrolling.
1 January 2027
Quick facts
| Lead sponsor | Jacobio Pharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 144 |
| Start date | 24 July 2024 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 July 2027 |
| Sites | 15 locations across United States, China |
Drugs / interventions tested
Conditions studied
- Solid Tumors — all drugs for Solid Tumors →
Sponsor
Jacobio Pharmaceuticals Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dose limiting toxicity (DLT)
Time frame: Approximately one year
Number and proportion of participants who experience at least one dose limiting toxicity (DLT) -
Number of participants with adverse events
Time frame: Approximately three years
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.
Sponsor's own description
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
TP53 Deficiency in the Natural History of Prostate Cancer.
Ofner H, Kramer G, Shariat SF, Hassler MR. · · 2025 · cited 4× · PMID 40002239 · DOI 10.3390/cancers17040645
Verify or expand the search:
- PubMed search for NCT06386146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumors
Currently open trials in the same condition.
- NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
- NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
- NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting
Other Jacobio Pharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT06959615 — A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration · Phase 1, PHASE2 · recruiting
- NCT05174585 — JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors · Phase 1, PHASE2 · completed
- NCT05002270 — JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation · Phase 1, PHASE2 · completed
- NCT04721223 — JAB-3068 Activity in Adult Patients With Advanced Solid Tumors · Phase 1, PHASE2 · completed
- NCT04587479 — A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06386146 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jacobio Pharmaceuticals Co., Ltd.
- Last refreshed: 20 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06386146.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing