This Study Aims to Evaluate the Efficacy and Safety of QLS1317 in Patients With MSI-H/dMMR Advanced Solid Tumors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS1317.
- Who it may be relevant to
- Registry conditions: MSI-H or dMMR Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS1317 in Participants With Advanced Solid Tumors Characterized by Microsatellite Instability-High (MSI-H)/Deficient DNA Mismatch Repair (dMMR) Advanced Solid Tumors
Overview
The goal of this study aims to evaluate the efficacy and safety of QLS1317 in patients with MSI-H/dMMR advanced solid tumors who failed standard treatment.
Interventions
- Drug QLS1317
Varying doses of QLS1317
Primary outcome measures
- Dose-Lmiting Toxicity (DLT), [Time frame: From time of first dose of QLS1317 to end of DLT period (25 days)]
- Maximum Tolerated Dose (MTD) [Time frame: 1 year]
- Recommended Phase ll Dose（RP2D） [Time frame: 2 years]
- Objective Remission Rate (ORR) [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
-1. Males or females aged ≥ 18 at the time of signing the informed consent form (ICF).
2\. Expected survival duration ≥ 3 months. 3. Participants with advanced solid tumors of MSI-H/dMMR who have failed standard treatment.
4\. At least one measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) physical performance status score of 0-1.
6\. Patients with sufficient organ function.
Exclusion criteria
- 1\. Have a history of allergy to any component of the study drug. 2. Oral medication is not allowed. 3. The residual toxic reactions caused by previous anti-tumor treatment are higher than Grade 1 according to CTCAE v6.0.
4\. Known or discovered during screening period to have active central nervous system metastasis.
5\. Having suffered from other malignant tumors within 5 years prior to the first dose.
6\. The presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require drainage or treatment.
7\. Chronic active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
8\. Suffering from severe cardiovascular and cerebrovascular diseases. 9. Any severe or uncontrollable systemic disease. 10. Have received allogeneic tissue/solid organ transplantation.
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
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07552376 · QLS1317-101