Seçilmiş RAS/MAPK Mutasyonu Pozitif Kanserlerde S241656'nın Faz 1/Faz 2 Çalışması

Sade dilde özet

Bu çalışma, RAS veya RAF gen değişiklikleri (KRAS, NRAS, HRAS, BRAF gibi) taşıyan ileri evre veya metastatik solid tümörlerde S241656 adlı deneysel ilacı, tek başına veya FOLFOX, FOLFIRI, Cetuximab, Panitumumab gibi tedavilerle birlikte incelemektedir. Çalışmaya, akciğer, pankreas, kolorektal ve diğer ilgili kanser türlerinde bu gen değişiklikleri doğrulanmış yetişkin hastalar alınabilmektedir. Çalışma Faz 1/Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Katılımcı alıyor

Sponsor

Institut de Recherches Internationales Servier

Müdahale

S241656, FOLFOX6/FOLFOX7, FOLFIRI, Cetuximab, Panitumumab, Gemcitabine, Nab-paclitaxel

Başlangıç

18.04.2023

Tahmini bitiş

01.06.2028

Ülkeler

United States, Denmark, Hong Kong, Japan, United Kingdom

İlgili genler

Merkezler

• Gilbert, United States
• Los Angeles, United States
• Los Angeles, United States
• San Francisco, United States
• Aurora, United States
• New Haven, United States
• Washington D.C., United States
• Boston, United States
• Grand Rapids, United States
• Minneapolis, United States
• St Louis, United States
• New York, United States
• New York, United States
• Durham, United States
• Cleveland, United States
• Nashville, United States
• Houston, United States
• San Antonio, United States
• Fairfax, United States
• Seattle, United States
• Copenhagen, Denmark
• Hong Kong, Hong Kong
• Kyoto, Japan
• Tokyo, Japan
• London, United Kingdom
• London, United Kingdom
• Manchester, United Kingdom

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Key Inclusion Criteria:

* Life expectancy of ≥ 12 weeks in the opinion of the investigator.
* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.
* Adequate bone marrow and organ function.
* Recovered from toxicity to prior anti-cancer therapy.

Part 1 Dose Escalation cohort ONLY:

* Part 1A: Advanced/metastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations
* Part 1B: Advanced/metastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1C: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1E: Other advanced/metastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations

Part 2 Dose Optimization and Expansion cohorts ONLY:

* Part 2A: Advanced/metastatic NSCLC with KRAS non-G12C mutations and/or BRAF mutations
* Part 2A1: Advanced/metastatic NSCLC with KRAS non-G12C mutations
* Part 2A2: Advanced/metastatic NSCLC with BRAF mutations
* Part 2A3: Advanced/metastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease
* Part 2A4: Advanced/metastatic NSCLC with a KRAS G12C mutation
* Part 2B1: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 2B2: Advanced/metastatic CRC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 2B3: Advanced/metastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations

Key Exclusion Criteria:

* Cancer that has a known MEK1/2 mutation.
* Known allergy/hypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.
* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.
* Major surgery within 4 weeks of study entry or planned during study.
* Ongoing anticancer therapy.
* Ongoing radiation therapy.
* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.
* Clinically significant cardiovascular disease.
* Symptomatic spinal cord compression.
* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Females who are pregnant or breastfeeding.
* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
* Prior use of experimental agents that target the KRAS/BRAF/MEK/ERK pathway.