Clinical Trials

Inclusion Criteria:

- Age ≥18 years at the time of informed consent.

- Histological or cytological diagnosis of ALK-positive advanced NSCLC, CRC with BRAF
V600E mutation, or RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumor.
Participants with ROS-positive NSCLC are also eligible for Part 1 and 2.

- Documentation evidence of biomarker mutation status.

- Part 3:

ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort
1); with prior lorlatinib and prior platinum-based chemotherapy (Cohort 2); or with no
prior lorlatinib (Cohort 3).

BRAF V600E mutant CRC participants resistant to BRAFi plus EGFRi (Cohort 4 ); refractory to
BRAFi plus EGFRi (Cohort 5); or BRAFi plus EGFRi naïve (Cohort 6).

RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior SOC
(Cohort 7).

Exclusion Criteria:

- Brain metastasis larger than 4 cm.

- Active malignancy within 3 years.

- Systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to
start of study treatment. Antibody based agents within 4 weeks prior to start of study
treatment. Mitomycin C or nitrosoureas within 6 weeks prior to start of study
treatment.

- For participants who may get lorlatinib or encorafenib on study, history of
interstitial lung disease.

- For participants who may get binimetinib on study, history or current evidence of
retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with
elevated creatine kinase (CK).

Eligibility last updated 5/27/22. Questions regarding updates should be directed to the study team contact.