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

ConditionMSI-H or dMMR Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Qilu Pharmaceutical Research and Development Center LTD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • QLS1317

    Drug

    Varying doses of QLS1317

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: QLS1317Experimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Qilu Pharmaceutical Research and Development Center LTD

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: