A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors

NCT06322095 | Recruiting Phase 2

• 1 other identifier: GH21C202
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This study is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors.

Conditions

Patients With Advanced Solid Tumor; Advanced Solid Tumor With Oncogenic Driver Mutations

Outcome Measures

Primary Outcomes (1)

• Objective 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).

  3 years

Secondary Outcomes (7)

• Number of Participants with Adverse Events

  3 years

• Duration of Response (DOR) Based on RECIST 1.1 Criteria

  3 years

• Disease Control Rate (DCR）Based on RECIST 1.1 Criteria

  3 years

• Progression-Free Survival (PFS) Based on RECIST 1.1 Criteria

  3 years

• Plasma Peak Concentration (Cmax)

  3 years

Study Arms (5)

'GH21+PD-1'Group

EXPERIMENTAL

GH21 combined with previous PD-1.

Drug: PD-1; Drug: GH21

'GH21+ALK Inhibitor'Group

EXPERIMENTAL

GH21 combined with previous ALK inhibitor.

Drug: ALK inhibitor; Drug: GH21

'GH21+MET Inhibitor'Group

EXPERIMENTAL

GH21 combined with previous MET inhibitor.

Drug: MET inhibitor; Drug: GH21

'GH21+BRAF Inhibitor+MEK Inhibitor'Group

EXPERIMENTAL

GH21 combined with previous BRAF inhibitor and MEK inhibitor.

Drug: BRAF Inhibito; Drug: GH21; Drug: MEK Inhibitor

'GH21+EGFR Monoclonal Antibody'Group

EXPERIMENTAL

GH21 combined with previous EGFR Monoclonal Antibody.

Drug: EGFR Monoclonal antibody; Drug: GH21

Interventions

PD-1 DRUG

Previous PD-1

'GH21+PD-1'Group

MET inhibitor DRUG

Previous MET inhibitor

'GH21+MET Inhibitor'Group

ALK inhibitor DRUG

Previous ALK inhibitor

'GH21+ALK Inhibitor'Group

BRAF Inhibito DRUG

Previous BRAF inhibitor

'GH21+BRAF Inhibitor+MEK Inhibitor'Group

EGFR Monoclonal antibody DRUG

Previous EGFR Monoclonal antibody

'GH21+EGFR Monoclonal Antibody'Group

GH21 DRUG

Oral, 15mg BIW or 6mg QD

'GH21+ALK Inhibitor'Group; 'GH21+BRAF Inhibitor+MEK Inhibitor'Group; 'GH21+EGFR Monoclonal Antibody'Group; 'GH21+MET Inhibitor'Group; 'GH21+PD-1'Group

MEK Inhibitor DRUG

Previous MEK Inhibitor

'GH21+BRAF Inhibitor+MEK Inhibitor'Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);
• Male or female subjects aged ≥18 years;
• Patients with advanced solid tumors confirmed by cytological or histological assessments;
• Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);
• Life expectancy of ≥ 3 months;
• ECOG PS score of 0-1;
• The subjects must have adequate organ functions;
• Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 6 months after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product.

You may not qualify if:

• Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following:
• Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product;
• Oral administration of fluorouracils, small molecule targeted drugs, and Chinese herbal medicines or Chinese patent medicines with antitumor indications within 5 half-lives or 2 weeks before the first dose of the investigational product (whichever is shorter);
• Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to the first dose of the investigational product (whichever is shorter);
• Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational product; Note: If the latest anti-tumor therapy before enrollment is only the intended combination therapy, follow-up therapy can be carried out according to the original treatment cycle according to clinical needs, without waiting for elution.
• Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product;
• Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study;
• Subjects who have received strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives prior to the first dose of the investigational product;
• Subjects with evidence of the following heart conditions:
• Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first dose of the investigational product;
• Grade III-IV heart failure diagnosed according to the cardiac function classification of the New York Heart Association at screening;
• Echocardiography (ECHO) shows the left ventricular ejection fraction (LVEF) ≤ 50% at screening;
• QT interval corrected by Fridericia method (QTcF) is ≥ 450 ms (male) or ≥ 470 ms (female) at screening;
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) despite of medication treatment at screening;
• Subjects with dysphagia, gastrointestinal disorders that affect drug absorption, or other malabsorption conditions, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, delayed gastric emptying, or severe gastrointestinal toxicities that have not resolved to Grade 2 or lower prior to the first dose of the investigational product; or subjects are diagnosed with a clinically significant or acute gastrointestinal disease;

Sponsors & Collaborators

• Suzhou Genhouse Bio Co., Ltd.: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100029, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

MeSH Terms

Interventions

1,1'-(4,4'-(((5-chloropyrimidine-2,4-diyl)bis(azanediyl))bis(3-methoxy-4,1-phenylene))bis(piperazine-4,1-diyl))diethanone; MEK inhibitor I

Study Officials

• Ning Li, Doctorate

  +86-10-87788495

  PRINCIPAL INVESTIGATOR

• Haidan Wang, Doctorate

  +86-512-86861608

  STUDY DIRECTOR

Central Study Contacts

Yiming Zhou, Bachelor

CONTACT

+86-512-86861608; zhouyiming@genhousebio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 20, 2024
• Study Start: March 22, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-03

Locations

CN (2)