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GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results

ConditionAdvanced Solid Tumors With MAPK Signal Pathway Mutations
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Genhouse Bio Co., Ltd.

About this trial

This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.

This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects aged 18-80 years (inclusive).

Patients with histologically or cytologically confirmed MAPK mutant (presence of RAS/RAF/MEK/ERK mutations) locally advanced or metastatic solid tumors.

Patients who have failed standard treatment or have no standard treatment regimen or are not suitable for standard treatment currently.

Dose escalation: At least one assessable tumor lesion according to RECIST version 1.1; Dose expansion: At least one measurable tumor lesion according to RECIST version 1.1 (tumor lesion located in the region of previous radiotherapy or other locoregional treatment sites is usually not considered a measurable lesion, unless this lesion shows clear progression or persists for 3 months after radiotherapy).

Disqualifiers

Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;

Use of oral fluorouracil(s), small molecule targeted drugs, and antitumor traditional Chinese medicine within 2 weeks prior to the first dose of the investigational drug;

Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.

Received other unmarketed clinical investigational drug or therapy within 4 weeks prior to the first dose.

Trial design

Design model

Single group

Treatments tested in this trial

  • GH55

    Drug

    GH55 capsule is a novel small molecule, highly selective dual-mechanism ERK1/2 inhibitor developed by Suzhou Genhouse Bio. Co., Ltd. This product can be used to treat cancers caused by abnormal activation of the MAPK pathway (mutational activation of RAS/RAF/MEK) by targeted inhibition of ERK1/2.

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: GH55 GROUPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting Toxicities Incidence Count Among Study Participants

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (phase I)

Time frame
2 years
2

Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (phase I)

Time frame
2 years
3

Response Rate (ORR) Based on RECIST 1.1 Criteria

ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (phase II)

Time frame
2 years

Secondary outcomes

1

Progression-free survival (PFS) Based on RECIST 1.1 Criteria

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (phase I/II)

Time frame
2 years
2

Duration of response (DOR) Based on RECIST 1.1 Criteria

DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (phase I/II)

Time frame
2 years
3

Number of participants with adverse events

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (phase II)

Time frame
2 years
4

Plasma concentration (Cmax)

Highest observed plasma concentration of GH55. (phase I/II)

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Suzhou Genhouse Bio Co., Ltd.

Lead sponsor

Shanghai East Hospital

Collaborator

Shandong Tumor Hospital

Collaborator

Source ClinicalTrials.gov
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