> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-i-clinical-study-of-qls-1304-in-the-treatment-of-e3f5a424-14a1-43c6-aa0d-1b6b9a4ad927 > Record changed: 2026-10-13 # Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors NCT06823609 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) Lead sponsor Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) Start date 2025-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Title and summary **Summary** This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Short title** Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Official title** A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **First posted** 2025-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Registry last updated** 2026-01-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Primary completion date** 2026-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Start date** 2025-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Lead sponsor** Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Identifiers **Registry ID** NCT06823609 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **ClinicalTrials.gov ID** NCT06823609 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Outcomes ### Primary outcomes 1. Dose limited toxicity (DLT) of QLS1304 Timeframe: up to 35 days 2. Maximum tolerated dose（MTD）of QLS1304 Timeframe: up to 35 days 3. Recommended Phase II Dose (RP2D) of QLS1304 Timeframe: up to 35 days ### Secondary outcomes 1. adverse event Timeframe: from the first drug administration to within 30 days for the last treatment dose 2. Cmax Timeframe: through study completion, an average of 2 year 3. objective response rate(ORR) Timeframe: through study completion, assessed up to 24 months 4. Tmax Timeframe: through study completion, an average of 2 year 5. AUC0-t Timeframe: through study completion, an average of 2 year 6. AUC0-inf Timeframe: through study completion, an average of 2 year 7. CL/F Timeframe: through study completion, an average of 2 year 8. Vd/F Timeframe: through study completion, an average of 2 year 9. MRT Timeframe: through study completion, an average of 2 year 10. t1/2 Timeframe: through study completion, an average of 2 year Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Volunteer to participate in this study, sign an informed consent form and have good compliance; - Age ≥ 18 years old, Male or female - ECOG score: 0-1 - Expected survival ≥ 12 weeks - Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology; - Failed to standard treatment or has no standard treatment scheme; - Baseline presence of at least one evaluable lesion according to the RECIST v1.1; - The functional level of important organs is basically normal, meeting the requirements of the scheme - Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication; - Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation. - Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent ### Exclusion criteria - 1\. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug. - Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug. - Subjects require long-term or high-dose use of non-steroidal drugs. - Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1. - Subjects have a known or suspected severe allergy to theinvestigational drug or any of its components Subjects have other active malignant tumors within 5 years before the first use of the investigational drug. - Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease. - Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment. - Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption. - Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug. - Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Sites - Fudan University Cancer HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06823609) ## Related records ### Drugs (1) - [LB-102](https://trialight.com/data/asset/lb-102-4fafa13e-2b6e-4289-b389-c2f1e2b594e9.md) ### Lead sponsors (1) - [Qilu Pharmaceutical Co., Ltd.](https://trialight.com/data/company/qilu-pharmaceutical-co-ltd-ea951f76-da25-4047-80d5-f47ba892d0a1.md) ### Conditions (1) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Primary condition --- ## 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. 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