NCT07552376

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
32mo left

Started May 2026

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2028

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

MSI-H or dMMR Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

QLS1317

EXPERIMENTAL
Drug: QLS1317

Interventions

QLS1317DRUG

Varying doses of QLS1317

QLS1317

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females aged ≥ 18 at the time of signing the informed consent form (ICF).
  • \. Expected survival duration ≥ 3 months. 3. Participants with advanced solid tumors of MSI-H/dMMR who have failed standard treatment.
  • \. At least one measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) physical performance status score of 0-1.
  • \. Patients with sufficient organ function.

You may not qualify if:

  • \. 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.
  • \. Known or discovered during screening period to have active central nervous system metastasis.
  • \. Having suffered from other malignant tumors within 5 years prior to the first dose.
  • \. The presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require drainage or treatment.
  • \. Chronic active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
  • \. Suffering from severe cardiovascular and cerebrovascular diseases. 9. Any severe or uncontrollable systemic disease. 10. Have received allogeneic tissue/solid organ transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yanhong Deng, Doctorate

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04