BridgeMD
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
EU CTIS ID: 2024-511798-31-00
What this study is testing
Phase 1 Part 1a and Part 2a Monotherapy Cohorts (Once Daily [QD] Dosing) – Advanced Solid Tumors -To evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors - To estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors Phase 1 Part 1b and Part 2b Monotherapy Cohorts (Twice Daily [BID] Dosing) – Advanced Solid Tumors Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD) – Advanced Solid Tumors (Fed State) - To evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts – Advanced Non-small Cell Lung Cancer (NSCLC) -To evaluate the safety and tolerability of AMG 510 in combination with pembrolizumab in adult subjects with KRAS p.G12C mutant advanced NSCLC Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort (QD) - To evaluate the safety and tolerability of AMG 510 in adult subjects with previously untreated, KRAS p.G12C mutant metastatic NSCLC - To evaluate tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of AMG 510 as monotherapy in adult subjects with previously untreated KRAS p.G12C mutant metastatic NSCLC Phase 2 Part A – NSCLC, CRC, and other tumor types (AMG 510 monotherapy) -To evaluate tumor objective response rate (ORR) assessed by RECIST 1.1 criteria of AMG 510 as monotherapy in subjects with KRAS p.G12C mutated advanced tumors (NSCLC, colorectal cancer [CRC], and other tumor types) Phase 2 Part B – NSCLC (Dose Comparison Study) -To evaluate tumor objective response rate (ORR) assessed by RECIST 1.1 criteria of AMG 510 960 mg QD and 240 mg QD as monotherapy in previously treated subjects with KRAS p.G12C mutated advanced NSCLC -To evaluate the safety and tolerability of AMG 510 960 mg QD and 240 mg QD in previously treated subjects with KRAS p.G12C-mutated advanced NSCLC.Phase 1 Part 1b and Part 2b Monotherapy Cohorts (Twice Daily [BID] Dosing) – Advanced Solid Tumors Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD) – Advanced Solid Tumors (Fed State) - To evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors.Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts – Advanced Non-small Cell Lung Cancer (NSCLC) -To evaluate the safety and tolerability of AMG 510 in combination with pembrolizumab in adult subjects with KRAS p.G12C mutant advanced NSCLC."Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort (QD) - To evaluate the safety and tolerability of AMG 510 in adult subjects with previously untreated, KRAS p.G12C mutant metastatic NSCLC - To evaluate tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of AMG 510 as monotherapy in adult subjects with previously untreated KRAS p.G12C mutant metastatic NSCLC.Phase 2 Part A – NSCLC, CRC, and other tumor types (AMG 510 monotherapy) -To evaluate tumor objective response rate (ORR) assessed by RECIST 1.1 criteria of AMG 510 as monotherapy in subjects with KRAS p.G12C mutated advanced tumors (NSCLC, colorectal cancer [CRC], and other tumor types).Phase 2 Part B – NSCLC (Dose Comparison Study) -To evaluate tumor objective response rate (ORR) assessed by RECIST 1.1 criteria of AMG 510 960 mg QD and 240 mg QD as monotherapy in previously treated subjects with KRAS p.G12C mutated advanced NSCLC -To evaluate the safety and tolerability of AMG 510 960 mg QD and 240 mg QD in previously treated subjects with KRAS p.G12C-mutated advanced NSCLC.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
You likely can't join if
- Active brain metastases from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United States
- Brazil
- Australia
- Japan
- Korea, Republic of
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United States; Brazil; Australia; Japan; Korea, Republic of and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.