Cancer, CRC (Colorectal Cancer), NSCLC, PDAC
Conditions
Keywords
cancer, RAS
Brief summary
This study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations. The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276. The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.
Interventions
DRUGGFH276
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Sponsors
Genfleet Therapeutics (Shanghai) Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. With a life expectancy of ≥3 moths 5. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion. 6. Adequate laboratory parameters during the screening period.
Exclusion criteria
1. Active brain metastases. 2. Prior treatment with a PAN-RAS inhibitor. 3. Palliative radiotherapy was completed within 14 days before the first dose. 4. Have poorly controlled or severe cardiovascular disease. 5. Subjects with active hepatitis B or active hepatitis C. 6. Known allergy to the study drug or its components. 7. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ia:The incidence of DLT events | 21 days | The incidence of DLT events |
| Phase II:Overall response rate (ORR) | about 48 months | Aassessed by investigators according to RECIST 1.1 |
| Efficacy endpoints | about 48 months | Duration of response (DoR) |
| Phase Ia:The incidence and severity of AEs and SAEs | 48 months | The incidence and severity of AEs and SAEs |
| Phase Ib:The incidence and severity of AEs and SAEs | 48 months | The incidence and severity of AEs and SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | about 48 months | he percentage of patients who achieved CR, PR and SD |
| Peak Plasma Concentration(Cmax) | about 48 months | — |
Countries
China
Contacts
Primary Contactpeng, PM
Outcome results
None listed