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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: MSI-H or dMMR Advanced Solid Tumors
• Intervention / Treatment: Drug: QLS1317

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanhong Deng, Doctorate; Phone Number: +86-13925106525; Email: dengyanh@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS1317	Drug: QLS1317; Varying doses of QLS1317

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai Qilu Pharmaceutical Research and Development Center LTD

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QLS1317-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No