Study of QLS5308 in Patients With Advanced Solid Tumors

NCT07462442 | Not Yet Recruiting Phase 1

• 1 other identifier: QLS5308-101
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLS5308 in patients with advanced solid tumors.

  up to 12 months

• 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

Secondary Outcomes (4)

• Objective Response Rate

  up to 36 months

• DOR

  up to 48 months

• PFS

  up to 48 months

• OS

  up to 60 months

Study Arms (1)

Arm A: QLS5308

EXPERIMENTAL

Drug: QLS5308 IV infusion

Interventions

QLS5308 IV infusion DRUG

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.

Arm A: QLS5308

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Shusen Wang, Doctor

CONTACT

13926168469; Wangshus@susucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 28, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2031
• Last Updated: March 10, 2026

Record last verified: 2026-02