Phase Ib/II Clinical Study of QLS5133 Combination Therapy in Advanced Solid Tumors
NCT07933419, Phase 1, Phase 2, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Phase Ib/II Clinical Study of QLS5133 Combination Therapy in Advanced Solid Tumors | ClinicalTrials.gov |
| NCT number | NCT07933419 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 558 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Qilu Pharmaceutical Co., Ltd. | ClinicalTrials.gov |
| Conditions | Clear Cell Renal Cell Carcinoma, Ovarian Cancer, Other Advanced Solid Tumors | ClinicalTrials.gov |
| Interventions | QLS5133; Lenvatinib mesylate, QLS5133; QL2107; Lenvatinib mesylate, QLS5133; Bevacizumab, QLS5133; Platinum; Bevacizumab, QLS5133; Olaparib; Bevacizumab, QLS5133; QL2107; Bevacizumab | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Phase Ib Outcome 1:Incidence and severity of adverse events and serious adverse events | up to 2 years | Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 6.0 | ClinicalTrials.gov |
| Primary | Phase Ib Outcome 2:Maximum tolerated dose (MTD) | 28 days | Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants | ClinicalTrials.gov |
| Primary | Phase Ib Outcome 3:Recommended Phase 2 Dose (RP2D) | up to 2 years | Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data | ClinicalTrials.gov |
| Primary | Phase II outcome 1:Objective response rate (ORR) (Arms 1B, 2B, 3B-3, 4B, 6B) | up to 2 years | ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria. | ClinicalTrials.gov |
| Primary | Phase II outcome 2:Progression-free survival (PFS) (Arms 3B-1, 3B-2, and 5B) | up to 2 years | PFS is defined as the duration from the date of first dose of study treatment to the date of first documented PD per investigator assessment, or death from any cause, whichever occurs first. | 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)