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NCT Number: NCT07552376

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-1. 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.

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.
  • 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.

Treatment and study plan

QLS1317

Drug

Varying doses of QLS1317

Primary outcomes

  1. Dose-Lmiting Toxicity (DLT),

    Time frame: From time of first dose of QLS1317 to end of DLT period (25 days)

  2. Maximum Tolerated Dose (MTD)

    Time frame: 1 year

  3. Recommended Phase ll Dose(RP2D)

    Time frame: 2 years

  4. Objective Remission Rate (ORR)

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Yanhong Deng, Doctorate

CONTACT

[email protected]

+86-13925106525

Sponsors and collaborators

Lead sponsor

Shanghai Qilu Pharmaceutical Research and Development Center LTD

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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