Clinical trial · Interventional
Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.
A Phase I Open-label, Multicenter Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1003 in Patients With ALK-positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC)
NCT03130881CI-TRIAL-00043793unknownPhase 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 phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PLB1003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PLB1003
- description
- ALK-positive (ALK+) advanced NSCLC
- interventionNames
- Drug: PLB1003
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs) .
- timeFrame
- 18 months.
- description
- The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment.
Secondary outcomes (4)
- measure
- Area under the plasma concentration versus time curve (AUC) of PLB1003 and its metabolite.
- timeFrame
- Day 1-3 PK Run-in period and Day 1-21 Treatment period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed Consent Form * Age≥18 years * Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy. * Must have evidence of ALK positivity from the results of molecular pre-screening evaluations * At least one measurable lesion as per RECIST v1.1 * Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 * ECOG Performance Status of 0-2 Exclusion Criteria: * Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits. * Clinically significant, uncontrolled heart diseases. Unstable angina. History of documented congestive heart failure (New York Heart Association functional classification III-IV) . * Active peptic ulcer disease or gastritis * Major surgery within 4 weeks prior to starting PLB1003 * Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003.. * Pregnant or nursing women * Involved in other clinical trials \< 30 days prior to Day 1
References
Publications (0)
Data not yet available
No reference posted for this study.