Study of QLS5308 in Patients With Advanced Solid Tumors

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLS5308 in patients with advanced solid tumors. [Time frame: up to 12 months]
• Number of participants who experience one or more adverse events(AEs). [Time frame: up to 48 months]

Secondary outcome measures (4)

• Objective Response Rate [Time frame: up to 36 months]
• DOR [Time frame: up to 48 months]
• PFS [Time frame: up to 48 months]
• OS [Time frame: up to 60 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07462442 · QLS5308-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗