Clinical trial · Interventional
A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
A Phase I, First-In-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
NCT05159700CI-TRIAL-00098930active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRJ1-3024 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy Escalation
- description
- 3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.
- interventionNames
- Drug: PRJ1-3024
Primary outcomes (1)
- measure
- Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
- timeFrame
- Day 1 to Day 21
- description
- Safety listings and pharmacokinetic listings will be used for evaluation
Secondary outcomes (6)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable. * Male or non-pregnant, non-lactating female subjects age ≥18 years. * ECOG Performance Status 0\~2. * Has at least 1 measurable lesion as defined by RECIST 1.1 criteria . * Life expectancy of \>3 months, in the opinion of the Investigator. * Able to take oral medications and willing to record daily adherence to investigational product. * Adequate hematologic parameters unless clearly due to the disease under study. * Adequate renal and hepatic function * Able to understand and willing to sign a written informed consent form. Key Exclusion Criteria: * History of another malignancy * Known symptomatic brain metastases requiring \>10 mg/day of prednisolone. * Significant cardiovascular disease * Known active HBV, HCV, AIDS-related illness. * Has received a live vaccine within 30 days * History of active autoimmune disorders or ongoing immunosuppressive therapy. * Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) . * Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.
References
Publications (0)
Data not yet available
No reference posted for this study.