> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-qls5308-in-patients-with-advanced-solid-tumors-77258750-dc6b-49a6-a162-f432e0064e1f > Record changed: 2026-10-13 # Study of QLS5308 in Patients With Advanced Solid Tumors NCT07462442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) Participants 192 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) Lead sponsor Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) Start date 2026-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Short title** Study of QLS5308 in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Official title** A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5308 Monotherapy in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Dates **Completion date** 2031-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **First posted** 2026-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Registry last updated** 2026-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Primary completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Start date** 2026-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Size and sites **Participants** 192 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Planned participants** 192 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Lead sponsor** Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Identifiers **Registry ID** NCT07462442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **ClinicalTrials.gov ID** NCT07462442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Study design **Allocation** Not applicable **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Outcomes ### Primary outcomes 1. The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLS5308 in patients with advanced solid tumors. Timeframe: up to 12 months 2. Number of participants who experience one or more adverse events(AEs). Timeframe: up to 48 months 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. ### Secondary outcomes 1. Objective Response Rate Timeframe: up to 36 months 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. 2. DOR Timeframe: up to 48 months 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. 3. PFS Timeframe: up to 48 months 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. 4. OS Timeframe: up to 60 months OS is defined as the time from randomization to death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07462442) ## Related records ### Drugs (1) - [Sirukumab](https://trialight.com/data/asset/sirukumab-8f8925da-967a-4b11-9973-96c8d4e7ba86.md) ### Lead sponsors (1) - [Qilu Pharmaceutical Co., Ltd.](https://trialight.com/data/company/qilu-pharmaceutical-co-ltd-ea951f76-da25-4047-80d5-f47ba892d0a1.md) ### Targets (1) - [IL6](https://trialight.com/data/target/il6-544ef182-1a34-5e37-8c4c-9f44dc78411c.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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