Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Anti-Infective Agents

Vitamins

Amino Acids

Pembrolizumab

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Bevacizumab

Atezolizumab

Carboplatin

Leucovorin

Fluorouracil

Irinotecan

Pemetrexed

Everolimus

Palbociclib

Afatinib

Trametinib

Sotorasib

Panitumumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Immunosuppressive Agents

Immunologic Factors

Tyrosine Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib only Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.

Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.

Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.

Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion

* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.

Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors

Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Sotorasib administered orally as a tablet.

Trametinib administered orally as a tablet.

RMC-4630 administered orally as a capsule.

RMC-4630

afatinib administered orally as a tablet.

pembrolizumab administered as an intravenous (IV) infusion.

Panitumumab administered as an IV infusion.

Carboplatin, pemetrexed, docetaxel administered as an IV infusion.

Carboplatin, pemetrexed, docetaxel, paclitaxel

Atezolizumab administered as an IV injection.

Palbociclib administered orally as a tablet.

MVASI® (bevacizumab-awwb) administered as an IV infusion.

MVASI® (bevacizumab-awwb)

TNO155

Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.

IV Chemotherapy (Regimen 1)

IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

IV Chemotherapy (Regimen 2)

BI 1701963

AMG 404

Amgen Call Center

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

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

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).

Intracranial disease control rate assessed per RANO-BM.

Intracranial duration of response assessed per RANO-BM.

Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Overall PFS assessed per RECIST 1.1 and RANO-BM.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)	NCT04185883	Advanced Solid ... Kirsten Rat Sar...	Sotorasib Trametinib RMC-4630 Afatinib Pembrolizumab Panitumumab Carboplatin, pe... Atezolizumab Palbociclib MVASI® (bevaciz... TNO155 IV Chemotherapy... IV Chemotherapy... BI 1701963 AMG 404 Everolimus	18 Years - 100 Years	Amgen
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)	NCT04185883	Advanced Solid ... Kirsten Rat Sar...	Sotorasib Trametinib RMC-4630 Afatinib Pembrolizumab Panitumumab Carboplatin, pe... Atezolizumab Palbociclib MVASI® (bevaciz... TNO155 IV Chemotherapy... IV Chemotherapy... BI 1701963 AMG 404 Everolimus	18 Years - 100 Years	Amgen

Spots Global Cancer Trial Database for carboplatin, pemetrexed, docetaxel, paclitaxel