A Study of QLS5133 Monotherapy in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS5133.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5133 Monotherapy in Subjects With Advanced Solid Tumors
Overview
The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion： * Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. Phase 1 dose escalation will use ATD + BOIN, the maximum sample size for each dose group is 12. For Phase 1 PK expansion, 1 to 4 appropriate doses will be selected. After the DLT observation period in the selected dose group up to 12 subjects (including those subjects in the dose escalation stage) can be further enrolled for PK expansion. * Phase 2: Evaluates QLS5133's anti-tumor efficacy in subjects with advanced solid tumors. at least 2 dose groups will be expanded.
Interventions
- Drug QLS5133
antibody drug conjugate (ADC)
Primary outcome measures
- Incidence and severity of adverse events and serious adverse events [Time frame: up to 2 years]
- Maximum tolerated dose (MTD) [Time frame: 28days]
- Recommended Phase 2 Dose (RP2D) [Time frame: up to 2 years]
- Objective Response Rate (ORR) [Time frame: up to 2 years]
Secondary outcome measures (12)
- Maximum Serum Concentration of QLS5133 (Cmax) [Time frame: 21 days]
- Maximum Serum Concentration of QLS5133 at Steady State (Cmax,ss) [Time frame: 63 days]
- Minimum Serum Concentration of QLS5133 at Steady State (Cmin,ss) [Time frame: 63 days]
- Time of Maximum Serum Concentration of QLS5133 (Tmax) [Time frame: 21 days]
- Terminal Half-life (T1/2) of Serum QLS5133 [Time frame: 63 days]
- Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5133 [Time frame: 21 days]
- Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5133 [Time frame: 63 days]
- Apparent Volume of Distribution (Vd) of QLS5133 [Time frame: 63 days]
- Clearance (CL) of QLS5133 [Time frame: 63 days]
- Duration of Response (DOR) [Time frame: up to 2 years]
- Progression Free Survival (PFS) [Time frame: up to 2 years]
- Time to Progression (TTP) [Time frame: 1 years]
Eligibility criteria
Inclusion criteria
- Aged ≥ 18 years on the day of signing the ICF, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
- Measurable disease, per RECIST v1.1;
- Adequate organ function;
- Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
Exclusion criteria
- Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
- Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
- Progressive or symptomatic brain metastases;
- Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
- History of significant cardiac disease, or poorly controlled diabetes mellitus;
- History of recurrent autoimmune diseases;
- History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- History of other active malignant tumors within 3 years before signing the informed consent form;
- If female, is pregnant or breastfeeding;
- Be allergic to any component of QLS5133 or its excipients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07061639 · QLS5133-101