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โ† Trials
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A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllGenfleet Therapeutics (Shanghai) Inc.
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In plain words

What the trial is, and whether it could suit you

A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 18 years 2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification 3. At least one measurable lesion according to RECIST v1.1 4. ECOG performance status 0 or 1 5. Life expectancy \> 3 months 6. Adequate organ function 7. Willing to provide written informed consent 8. Fertile participants must use effective contraception Exclusion Criteria: 1. Other active malignancy within 3 years 2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor 3. History of active clinically significant cardiovascular dysfunction 4. For participants with known concomitant second oncodriver for PDAC or for solid tumors. 5. With active infection (HIV, HBV, HCV, syphilis) 6. The presence of clinical or radiological evidence of intestinal obstruction. 7. Prior anticancer therapy within 28 days or 5 half-lives 8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months 9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures. 10. History of central nervous system (CNS)disease 11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment. 12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
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What it tests

  • GFH276
  • Cetuximab
  • Nab paclitaxel
  • Gemcitabine
  • Fluorouracil
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Where

17 sites
Concord Cancer Centre, Concord Repatriation General Hospital, Sydney Local Health District
Concord, Australia
Macquarie University / Clinical Trials Unit
North Ryde, Australia
The Queen Elizabeth Hospital
Woodville South, Australia
Monash Health (Monash Medical Centre)
Clayton, Australia
Northern Health
Epping, Australia
PASO Medical
Frankston, Australia
Peking Union Medical College Hospital
Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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