Clinical trial · Interventional
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
NCT04014257CI-TRIAL-00053929completedPhase 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 study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.
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 |
|---|---|---|---|
| Phase 1 | — | UNRESOLVED | — |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NOV1601(CHC2014) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NOV1601(CHC2014)
- description
- a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A(TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC)
- interventionNames
- Drug: NOV1601(CHC2014)
Primary outcomes (1)
- measure
- the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601
- timeFrame
- Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28).
- description
- MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).
Secondary outcomes (1)
- measure
- Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria(partial): * Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease * At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 or Response Assessment in Neuro-Oncology(RANO) * Relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable * Patients with primary central nervous system(CNS) tumors or metastasis, if they have been neurologically stable * Symptoms should be under control by stable dose of glucocorticoids and analgesic drugs for symptom control at least 2 weeks prior to starting the treatment * Stable dose of glucocorticoids and analgesic drugs for symptom control should be maintained throughout the study * Subjects should be off from radiotherapy for at least 14 days prior to the start of study treatment(C1D1) without symptom aggravation Exclusion Criteria(partial): * Prior high-dose chemotherapy requiring hematopoietic stem cell transplantation * History or evidence of suspicious leptomeningeal disease * Previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule * Indwelling percutaneous drainage of bile and chest tube * Evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.