Clinical trial · Interventional
A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients
NCT05830045CI-TRIAL-00078354unknownPhase 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 the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced solid tumors.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLP2117 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ia： QLP2117 Dose escalation and PK expansion
- interventionNames
- Drug: QLP2117
- type
- EXPERIMENTAL
- label
- Ib：QLP2117 Dose expansion
- interventionNames
- Drug: QLP2117
Primary outcomes (3)
- measure
- Dose-limiting toxicity(DLT)
- timeFrame
- 21days
- measure
- Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 2. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion) 3. Eastern Cooperative Oncology Group Performance Status of 0 or 1 4. Agree to provide archived tumor tissue samples of primary or metastatic lesions. 5. Have adequate organ function as described in the protocol. Exclusion Criteria: 1. Women who are pregnant or breastfeeding 2. HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication 3. Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment 4. Has an active autoimmune disease that has required systemic treatment in past 2 years. 5. Has an active infection requiring systemic therapy 6. Has received a live vaccine wihtin 30 days of planned start of study treatment 7. Has know history of, or any evidence of interstitial lung disease
References
Publications (0)
Data not yet available
No reference posted for this study.