OncoMatch/Clinical Trials/NCT06299839
PAS-004 in Patients With Advanced Solid Tumors
Is NCT06299839 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PAS-004 Capsules and PAS-004 Tablets for ras mutation.
Treatment: PAS-004 Capsules · PAS-004 Tablets — The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have. Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, or until: * They decide to withdraw from the study, or * They experience unacceptable side effects, or * Their disease progresses, or another illness interferes with taking the study drug, or * The sponsors stops the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: KRAS mutation
Documented evidence of rat sarcoma virus (RAS)...mutations
Required: NRAS mutation
Documented evidence of rat sarcoma virus (RAS)...mutations
Required: HRAS mutation
Documented evidence of rat sarcoma virus (RAS)...mutations
Required: NF1 mutation
Documented evidence of neurofibromatosis type I (NF1)...mutations
Required: ARAF mutation
Documented evidence of rapidly accelerated fibrosarcoma (RAF) mutations
Required: BRAF mutation
Documented evidence of rapidly accelerated fibrosarcoma (RAF) mutations. Patients with RAF mutations must have previously failed v-Raf murine sarcoma viral oncogene homolog B (BRAF) / MEK inhibition.
Required: CRAF mutation
Documented evidence of rapidly accelerated fibrosarcoma (RAF) mutations
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: BRAF inhibitor
Patients with RAF mutations must have previously failed v-Raf murine sarcoma viral oncogene homolog B (BRAF) / MEK inhibition.
Must have received: MEK inhibitor
Patients with RAF mutations must have previously failed v-Raf murine sarcoma viral oncogene homolog B (BRAF) / MEK inhibition.
Cannot have received: any antitumor therapy
Having received chemotherapy, radiotherapy, major surgery, targeted therapy, immunotherapy, or other antitumor treatment within 21 days of enrollment or five half-lives of the administered therapy, whichever occurs first.
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥ 90 g/L (without transfusion within 2 weeks of sample)
Kidney function
Creatinine clearance ≥ 45 mL/min (Cockcroft-Gault)
Liver function
Serum total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN if hemolysis or congenital hemolytic diseases); AST ≤ 2.5 × ULN or 5 × ULN for liver metastases; ALT ≤ 2.5 × ULN or 5 × ULN for liver metastases; Albumin ≥2 mg/dL
Patient must have adequate organ function at screening as indicated by the following laboratory value ranges: Serum total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN if hemolysis or congenital hemolytic diseases); AST ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases; ALT ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases; Albumin ≥2 mg/dL; Creatinine clearance ≥ 45 mL/min (as calculated per Cockcroft-Gault); ANC ≥ 1.5×109/L; Platelets ≥ 100×109/L; Hemoglobin ≥ 90 g/L (Note: Criteria must be met without a transfusion within 2 weeks of obtaining the sample)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NEXT Oncology · Austin, Texas
- NEXT Oncology · Irving, Texas
- NEXT Oncology · San Antonio, Texas
- NEXT Oncology · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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