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A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

ConditionsKRAS G12D MutationsAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGenfleet Therapeutics (Shanghai) Inc.

About this trial

This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Male or female ≥ 18 years old and ≤75 years old.

ECOG performance status of 0-1.

With a life expectancy of ≥12 weeks.

Disqualifiers

Active brain metastases.

Prior treatment with a KRAS G12D inhibitor.

Palliative radiotherapy was completed within 14 days before the first dose.

Have poorly controlled or severe cardiovascular disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • GFH375

    Drug

    GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Treatment groups

407 Participants
are divided into 1 treatment group
Group A: GFH375Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase Ia:The incidence and severity of AEs and SAEs

The incidence and severity of AEs and SAEs

Time frame
24 months
2

Phase Ia:The incidence of DLT events

The incidence of DLT events

Time frame
21 days
3

Phase Ib:The incidence and severity of AEs and SAEs

The incidence and severity of AEs and SAEs

Time frame
24 months
4

Phase II:Overall response rate (ORR)

For NSCLC cohort： Assessed by BICR according to RECIST 1.1；For other cohorts： Assessed by investigators according to RECIST 1.1；

Time frame
24 months

Secondary outcomes

1

Plasma concentrations

Plasma concentrations and PK parameters of GFH375

Time frame
up to 21 days
2

Efficacy endpoints

Duration of response (DoR)

Time frame
24 months
3

Efficacy endpoints

Disease control rate (DCR)

Time frame
24 months
4

Efficacy endpoints

Progression free survival (PFS)

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Genfleet Therapeutics (Shanghai) Inc.

Lead sponsor

Source ClinicalTrials.gov
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