This Study Aims to Evaluate the Efficacy and Safety of QLS1317 in Patients With MSI-H/dMMR Advanced Solid Tumors.

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07552376

Enrollment

120

Registered

2026-04-27

Start date

2026-05-01

Completion date

2028-12-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MSI-H or dMMR Advanced Solid Tumors

Brief summary

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

DRUGQLS1317

Varying doses of QLS1317

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Dose-Lmiting Toxicity (DLT),	From time of first dose of QLS1317 to end of DLT period (25 days)
Maximum Tolerated Dose (MTD)	1 year
Recommended Phase ll Dose（RP2D）	2 years
Objective Remission Rate (ORR)	2 years

Contacts

CONTACTYanhong Deng, Doctorate

dengyanh@mail.sysu.edu.cn+86-13925106525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026