A Study of QLS5314 Monotherapy in Participants With Advanced Solid Tumors
NCT07915856, Phase 1, Not yet recruiting, Shanghai Qilu Pharmaceutical Research and Development Center LTD
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of QLS5314 Monotherapy in Participants With Advanced Solid Tumors | ClinicalTrials.gov |
| NCT number | NCT07915856 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 70 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai Qilu Pharmaceutical Research and Development Center LTD | ClinicalTrials.gov |
| Conditions | Advanced Solid Tumors | ClinicalTrials.gov |
| Interventions | QLS5314 | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety and Tolerability: Incidence and Severity of Adverse Events | From informed consent through 30 days (±7 days) after the last dose; treatment for up to 2 years. | Number and percentage of participants with adverse events (AEs), treatment-emergent AEs (TEAEs), treatment-related AEs (TRAEs) and serious AEs (SAEs), by severity graded according to NCI-CTCAE v6.0 and relationship to QLS5314. | ClinicalTrials.gov |
| Primary | Incidence of Dose-Limiting Toxicities (DLTs) | Cycle 1 Days 1-21 following first administration of QLS5314. | Number and percentage of participants with protocol-defined DLTs during the Phase 1a dose-escalation stage. | ClinicalTrials.gov |
| Primary | Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) | From the first dose until completion of Phase Ia dose escalation, up to approximately 11 months. | MTD established using protocol-defined dose-escalation rules, or MAD if an MTD is not established. | ClinicalTrials.gov |
| Primary | Recommended Phase 2 Dose (RP2D) | From the first dose until determination of the RP2D, up to approximately 20 months. | RP2D determined using cumulative safety, tolerability, pharmacokinetic, immunogenicity, pharmacodynamic, biomarker and preliminary efficacy data. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)