Clinical trial · Interventional
An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
NCT06083870CI-TRIAL-00072420unknownPhase 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 will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
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 Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oba01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oba01
- interventionNames
- Drug: Oba01
Primary outcomes (1)
- measure
- maximal tolerance dose (MTD) of Oba01
- timeFrame
- DLT will be evaluated on 21 days of observation period
- description
- Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
Secondary outcomes (5)
- measure
- Overall response rate(ORR)
- timeFrame
- Up to approximately 2 years
- description
- The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment. * Histologically and/or cytologically-confirmed locally advanced or metastatic NSCLC. * Measurable lesion according to RECIST 1.1. * Progression after systemic treatment for advanced NSCLC. * Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Measurable and/or non-measurable disease as per RECIST 1.1 criteria. * Adequate organ function as assessed by laboratory tests. * Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment. Exclusion Criteria: * Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate. * Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment. * Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA \> ULN. * Pregnancy, lactation, or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.