Study of QLS5308 in Patients With Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5308 Monotherapy in Participants With Advanced Solid Tumors

The goal of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS5308 monotherapy in participants with Advanced Solid Tumors. This study is divided into two phases: Phase Ia is the dose escalation phase, where dose escalation of QLS5308 conducted and RP2D is explored; In the Phase Ib tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLS5308 with advanced solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Solid Tumors
• Intervention / Treatment: Drug: QLS5308 IV infusion

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shusen Wang, Doctor; Phone Number: 13926168469; Email: Wangshus@susucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1.
• Has adequate organ function.
• The expected survival period is ≥3 months.
• Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.
• According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.

Exclusion Criteria:

• Prior treatment with LIV1-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.
• There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.
• Active, uncontrolled bacterial, fungal or viral infections.
• Participants with moderate to large amounts of uncontrolled pleural, pericardial, or peritoneal effusions before the first dose (those who remain stable for at least 2 weeks after drainage may be enrolled).
• Subjects with a history of a second malignant tumor other than the target indication within 3 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.).
• Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2.
• Active autoimmune disease that requires systemic treatment or has the potential to recur.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: QLS5308	Drug: QLS5308 IV infusion; Participants will receive escalating doses of QLS5308 (0.8, 1.6, 3.2, 4.0, 4.8, 5.6, 6.4 mg/kg) intravenously on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who experience one or more adverse events(AEs).	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	up to 48 months
The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLS5308 in patients with advanced solid tumors.		up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator.	up to 36 months
DOR	For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator.	up to 48 months
PFS	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version1.1 (RECIST 1.1). PD is defined as ≥20%increase in the sum of diameters of target lesions. In addition to the relative increase of20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearanceof one or more new lesions is alsoconsidered PD. PFS as assessed by investigator.	up to 48 months
OS	OS is defined as the time from randomization to death due to any cause.	up to 60 months

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 28, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QLS5308-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No