Clinical trial NCT06932094: Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion):

* Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.
* Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1\~3 selected dose levels follow successful Phase 1a results.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumors;
* Measurable disease, per RECIST v1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* 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;

Exclusion Criteria:

* Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
* Progressive or symptomatic brain metastases;
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
* History of significant cardiac disease, or poorly controlled diabetes mellitus;
* History of recurrent autoimmune diseases;
* History of myelodysplastic syndrome (MDS) or 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 QLS5132 or its excipients.

Primary outcomes:
measure: Incidence and severity of adverse events and serious adverse events
timeFrame: up to 2 years
measure: Maximum tolerated dose (MTD)
timeFrame: 28days
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: up to 2 years
Secondary outcomes:
measure: Maximum Serum Concentration of QLS5132 (Cmax)
timeFrame: 21 days
measure: Maximum Serum Concentration of QLS5132 at Steady State (Cmax,ss)
timeFrame: 63 days
measure: Minimum Serum Concentration of QLS5132 at Steady State (Cmin,ss)
timeFrame: 63 days
measure: Time of Maximum Serum Concentration of QLS5132 (Tmax)
timeFrame: 21 days
measure: Terminal Half-life (T1/2) of Serum QLS5132
timeFrame: 63 days
measure: Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5132
timeFrame: 21 days
measure: Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5132
timeFrame: 63 days
measure: Volume of Distribution (Vd) of QLS5132
timeFrame: 63 days
measure: Clearance (CL) of QLS5132
timeFrame: 63 days
measure: Objective Response Rate (ORR)
timeFrame: up to 2 years
measure: Duration of Response (DOR)
timeFrame: up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: up to 2 years
measure: Time to Progression (TTP)
timeFrame: 1 years
measure: 1 Year Overall Survival (1YOS)
timeFrame: up to 2 years
measure: 2 Year Overall Survival (2YOS)
timeFrame: 2 years
measure: Number of anti-drug antibody (ADA) Positive Participants
timeFrame: up to 2 years
measure: Number of neutralizing antibody (Nab) Positive Participants
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
Study officials:
References: