Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors
NCT06823609
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Start date
2025-03-06
Number of sites
- 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.
- Short title
- Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2025-02-12
- Registry last updated
- 2026-01-13
- Primary completion date
- 2026-11-01
- Start date
- 2025-03-06
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06823609
- ClinicalTrials.gov ID
- NCT06823609
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Dose limited toxicity (DLT) of QLS1304
Timeframe: up to 35 days
Maximum tolerated dose（MTD）of QLS1304
Timeframe: up to 35 days
Recommended Phase II Dose (RP2D) of QLS1304
Timeframe: up to 35 days
adverse event
Timeframe: from the first drug administration to within 30 days for the last treatment dose
Cmax
Timeframe: through study completion, an average of 2 year
objective response rate(ORR)
Timeframe: through study completion, assessed up to 24 months
Tmax
Timeframe: through study completion, an average of 2 year
AUC0-t
Timeframe: through study completion, an average of 2 year
AUC0-inf
Timeframe: through study completion, an average of 2 year
CL/F
Timeframe: through study completion, an average of 2 year
Vd/F
Timeframe: through study completion, an average of 2 year
MRT
Timeframe: through study completion, an average of 2 year
t1/2
Timeframe: through study completion, an average of 2 year
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
- 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
- Fudan University Cancer HospitalShanghai, ChinaRecruiting
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Cancer Primary condition