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A Study to Evaluate YF087 in Subjects With MSI-H or dMMR Advanced Solid Tumors

ConditionAdvanced Solid Tumor Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInventisBio Co., Ltd

About this trial

This is an open-label, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of YF087 in subjects with Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with locally advanced (unresectable) or metastatic solid tumors;

dMMR/MSI-H status demonstrated in tumor tissue, blood, or other samples containing cancer cells or DNA;

Subjects must have experienced disease progression after the most recent therapy for advanced disease (prior therapy must include at least one PD-1/PD-L1 inhibitor treatment).

Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria;

Disqualifiers

Prior treatment with a WRN inhibitor such as HRO760, RO7589831, GSK4418959 and NDI-219216;

Prior to the first dose of study intervention, receipt of any anticancer treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational medicinal product within 14 days or 3 half-lives (whichever is shorter);

Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis and/or brainstem metastases and/or spinal cord compression;

Subjects with clinically significant cardiovascular and cerebrovascular disease

Trial design

Design model

Single group

Treatments tested in this trial

  • YF087

    Drug

    Dosage form: Tablet • Administration route: Oral, once a day

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: YF087Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of subjects participants with adverse events

Number of subjects participants with adverse events

Time frame
From enrollment to 30 days after last dose
2

Subject incidence of Dose-limiting toxicities (DLT)

Time frame
From enrollment to Cycle 1 Day 21
3

Objective response rate (ORR)

Time frame
From enrollment to the end of treatment, about 1 year

Secondary outcomes

1

Disease control rate (DCR)-assessed by IRC and investigators

Time frame
From enrollment to the end of treatment, about 1 year
2

Progression free survival (PFS)

Time frame
From enrollment to the end of treatment, about 1 year
3

Duration of Response (DOR)

Time frame
From enrollment to the end of treatment, about 1 year
4

Change from baseline in QT/QTc interval

Time frame
On Cycle 0 Day 1 and Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)

Other outcomes

1

Change from baseline in concentration and/or mutations in ctDNA

Time frame
From enrollment to the end of treatment, about 1 year

Locations

This trial has no locations.

Sponsors and contacts

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

InventisBio Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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