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This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A：GFH375 in combination with Cetuximab | Experimental | Arm A will enroll participants with locally advanced or metastatic solid tumors with KRAS G12D mutation. |
|
| Arm B：GFH375 in combination with AG | Experimental | Arm B will enroll participants with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFH375 | Combination Product | GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events | up to 28 days | |
| Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE) | From the first dose until 30 days after the last dose, assessed up to 24 months | |
| Phase II: Objective Response Rate (ORR) Evaluated by RECIST 1.1 | From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of GFH375 | Plasma concentrations of GFH375 | up to 6 months |
| Phase II: Incidence and Severity of AE and SAE | From the first dose until 30 days after the last dose, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yolanda Zeng | Contact | +8618073129952 | yaozeng@genfleet.com | |
| Junnan Dong | Contact | +8615521118409 | jndong@genfleet.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
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|
| GFH375 | Combination Product | GFH375 once daily (QD). Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle. |
|
|
| DCR | DCR assessed by investigators | From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| TTR | TTR assessed by investigators | From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| DOR | DoR assessed by investigators | From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| PFS | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors | From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| OS | Overall Survival | From the first dose until date of death from any cause, assessed up to 24 months |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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