Clinical trial · Interventional
A Phase I Study of QL1604 for Advanced Solid Tumors
A Phase I Clinical Study to Evaluate Safety、 Tolerability, and Pharmacokinetics of QL1604 for the Treatment of Advanced Solid Tumors - A Phase Ic Preliminary Efficacy Expansion Study
NCT05801094CI-TRIAL-00065385unknownPhase 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)
In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1604 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QL1604
- interventionNames
- Drug: QL1604
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- up to 2 years
- description
- ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Key Inclusion Criteria: * 18-75 years; * At least one measureable lesion as defined per RECIST Version (v) 1.1 * Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis * Adequate important organ function Key Exclusion Criteria: * Active autoimmune disease orautoimmune disease history * Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of \> 10 mg/day or equivalent hormone) for more than 2 weeks) * Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients * Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks) * Active hepaititis B or C infection * Both HBsAg and anti-HCV Ab positive
References
Publications (1)
- DERIVEDXiong J, Ouyang W, Yang M, Gao Z, Zhou H, Lou H, Guo Y, Xu Z, Zheng L, Liu Y, Wang Z, Sun P, Niyazi H, Wang J, Chen Y, Zhang B, Li L, Kang X, Guo W. Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study. Adv Ther. 2024 Nov;41(11):4153-4171. doi: 10.1007/s12325-024-02981-z. Epub 2024 Sep 14. PMID 39276185