A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

Conditions

Malignancies with Documented KRAS, BRAF and Other Selected RAS/MAPK Mutations

Brief summary

Dose Escalation: Incidence of dose-limiting toxicities occurring within the first 28-day cycle Number of Adverse Events and Serious Adverse Events Dose Expansion: Objective response

Detailed description

1. Dose Escalation: PK parameters of S241656 and its metabolite S243796, including but not limited to Cmax, tmax, AUC, and t½, 2. Dose Escalation: Objective response Disease Control Clinical Benefit Duration of Response Time to response Progression free survival Overall survival, 3. Dose Escalation: Clinical efficacy parameters Safety and tolerability parameters PK including: Exposure-toxicity relationship, 4. Dose Expansion: Clinical Efficacy Parameters Safety and Tolerability Parameters PK & PD parameters, 5. Dose Expansion: Disease Control Clinical Benefit Duration of Response Time to Response Progression free survival Overall Survival, 6. Dose Expansion: PK parameters of S241656 and its metabolite S243796, but not limited to Cmax, tmax, AUC, and t½

Related papers

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Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGFOLINATE DE CALCIUM HIKMA 10 mg/mL

DRUGsolution injectable/pour perfusion

DRUGOxaliplatin Kabi 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGS241656 film-coated tablet 50mg

DRUGErbitux 5 mg/mL solution for infusion

DRUGVectibix 20 mg/ml concentrate for solution for infusion

DRUGS241656 film-coated tablet 25mg

DRUGGemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGBugvi 5 mg/ml pulbere pentru dispersie perfuzabilă

DRUGIrinotecan Kabi 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGS241656 film-coated tablet 200mg

DRUGFluorouracil Hikma 50 mg/ml Injektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Escalation: Incidence of dose-limiting toxicities occurring within the first 28-day cycle Number of Adverse Events and Serious Adverse Events Dose Expansion: Objective response	—

Secondary

Measure	Time frame
1. Dose Escalation: PK parameters of S241656 and its metabolite S243796, including but not limited to Cmax, tmax, AUC, and t½, 2. Dose Escalation: Objective response Disease Control Clinical Benefit Duration of Response Time to response Progression free survival Overall survival, 3. Dose Escalation: Clinical efficacy parameters Safety and tolerability parameters PK including: Exposure-toxicity relationship, 4. Dose Expansion: Clinical Efficacy Parameters Safety and Tolerability Parameters PK & PD parameters, 5. Dose Expansion: Disease Control Clinical Benefit Duration of Response Time to Response Progression free survival Overall Survival, 6. Dose Expansion: PK parameters of S241656 and its metabolite S243796, but not limited to Cmax, tmax, AUC, and t½	—

Measure

Time frame

1. Dose Escalation: PK parameters of S241656 and its metabolite S243796, including but not limited to Cmax, tmax, AUC, and t½, 2. Dose Escalation: Objective response Disease Control Clinical Benefit Duration of Response Time to response Progression free survival Overall survival, 3. Dose Escalation: Clinical efficacy parameters Safety and tolerability parameters PK including: Exposure-toxicity relationship, 4. Dose Expansion: Clinical Efficacy Parameters Safety and Tolerability Parameters PK & PD parameters, 5. Dose Expansion: Disease Control Clinical Benefit Duration of Response Time to Response Progression free survival Overall Survival, 6. Dose Expansion: PK parameters of S241656 and its metabolite S243796, but not limited to Cmax, tmax, AUC, and t½

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Outcome results

None listed