NCT04185883 is a Phase 1 clinical trial of Sotorasib in Advanced Solid Tumors, sponsored by Amgen.

Who is sponsoring NCT04185883?

NCT04185883 is sponsored by Amgen.

What drugs are being tested in NCT04185883?

Interventions in NCT04185883: Sotorasib, Trametinib, RMC-4630, Afatinib, Pembrolizumab, Panitumumab, Carboplatin, pemetrexed, docetaxel, paclitaxel, Atezolizumab, Palbociclib, MVASI® (bevacizumab-awwb), TNO155, IV Chemotherapy (Regimen 1), IV Chemotherapy (Regimen 2), BI 1701963, AMG 404, Everolimus.

What condition does NCT04185883 study?

NCT04185883 studies Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation.

Is NCT04185883 still recruiting?

NCT04185883 is currently active, enrolled. Last updated 22 October 2025.

Last reviewed 2025-10-22 · How we verify

NCT04185883

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Active, enrolled Phase 1 Last updated 22 October 2025

What this trial tests

Phase 1 trial testing Sotorasib in Advanced Solid Tumors in 610 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 December 2019

Primary endpoint
17 December 2026

5 December 2027

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	610
Start date	17 December 2019
Primary completion	17 December 2026
Estimated completion	5 December 2027
Sites	90 locations across Italy, Japan, Netherlands, Belgium, Austria, Taiwan, United Kingdom, Germany

Drugs / interventions tested

Sotorasib (SOTORASIB) — full drug profile →
Trametinib (trametinib) — full drug profile →
RMC-4630
Afatinib
Pembrolizumab (pembrolizumab) — full drug profile →
Panitumumab
Carboplatin, pemetrexed, docetaxel, paclitaxel
Atezolizumab
Palbociclib
MVASI® (bevacizumab-awwb)
TNO155 — full drug profile →
IV Chemotherapy (Regimen 1)
IV Chemotherapy (Regimen 2)
BI 1701963
AMG 404
Everolimus (everolimus) — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Kirsten Rat Sarcoma (KRAS) pG12C Mutation — all drugs for Kirsten Rat Sarcoma (KRAS) pG12C Mutation →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 100, any sex, with Advanced Solid Tumors or Kirsten Rat Sarcoma (KRAS) pG12C Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Sotorasib for Lung Cancers with KRAS p.G12C Mutation.
Skoulidis F, Li BT, Dy GK, Price TJ, et al · · 2021 · cited 1383× · PMID 34096690 · DOI 10.1056/nejmoa2103695
KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors.
Hong DS, Fakih MG, Strickler JH, Desai J, et al · · 2020 · cited 1333× · PMID 32955176 · DOI 10.1056/nejmoa1917239
Acquired Resistance to KRASG12C Inhibition in Cancer.
Awad MM, Liu S, Rybkin II, Arbour KC, et al · · 2021 · cited 949× · PMID 34161704 · DOI 10.1056/nejmoa2105281
KRAS mutation: from undruggable to druggable in cancer.
Huang L, Guo Z, Wang F, Fu L. · · 2021 · cited 728× · PMID 34776511 · DOI 10.1038/s41392-021-00780-4
Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer.
Strickler JH, Satake H, George TJ, Yaeger R, et al · · 2023 · cited 391× · PMID 36546651 · DOI 10.1056/nejmoa2208470
The current state of the art and future trends in RAS-targeted cancer therapies.
Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
Diverse alterations associated with resistance to KRAS(G12C) inhibition.
Zhao Y, Murciano-Goroff YR, Xue JY, Ang A, et al · · 2021 · cited 348× · PMID 34759319 · DOI 10.1038/s41586-021-04065-2

Verify or expand the search:

Other trials of Sotorasib

Trials testing the same drug.

NCT07012031 — Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell · Phase 1, PHASE2 · recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer · EARLY_PHASE1 · not yet recruiting
NCT07172919 — A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation · Phase 2 · recruiting
NCT07143513 — Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients · completed
NCT06804824 — A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid T · Phase 1 · recruiting

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04185883 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 22 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04185883.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing