Randwick, Sydney, Australia

Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-12)

Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial for HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1). Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. Participants who complete the Double-blind Treatment Period (Week 52) may be eligible to enter a 52-week extension trial (HZNP- HZN-825-302). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

Study to evaluate HZN-825 in patients with Idiopathic Pulmonary Fibrosis (IPF)

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in subjects with IPF. Subjects will be screened within 8 weeks prior to the Baseline (Day 1) Visit. Approximately 360 subjects who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks using the following 2 stratification factors: Prior use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no; FVC % predicted at Baseline: ≥70% or <70%.

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

* Interventional Study * Estimated Enrollment:170 participants * Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations. * This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. * There is no difference in the treatment regimen between the cohorts.

A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy (KRYSTAL-10)

Gemini Trial

This study will last for a period of up to 21 months. An 18-month screening period is planned for evaluating patients that are not currently experiencing flares of GPP, and will be re-evaluated every 6 months, or upon experiencing a flare. Once the patient is in flare, he or she may begin the screening period (Part 2) to continue the journey towards the study treatment day. During the treatment period, there are 8 visits over a 3-month period. Visits take approximately 1 to 3 hours each, except for the screening visit of part 2 that may take up to 4 hours. Several blood samples will be collected on Day 1, Day 3, Week 1, Week 2, Week 4, Week 8 and Week 12. During the study visits, a physical evaluation of your GPP and overall health will be done by the study team. Non-invasive tape stripping to collect surface skin tissue samples will also be performed, and photography of your lesions will be conducted. You may be offered to take part in another optional aspect of the trial, which includes additional blood draws and skin biopsies of your GPP lesions. For the biopsy portion, there will be a total of three punch biopsies. At the end of the study, participants may be eligible to participate in the subsequent long term extension study, which may allow participants to receive the study treatment as a monthly injection under the skin, regardless of what they received during the first study. More information will be made available to you should you be interested. For more information and to register to the study, please visit the study page: https://gpptrial.com/

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation