Neumarkt I.d.opf., Germany

A Study of FT-4202 in Adults and Adolescents With Sickle Cell Disease (Hibiscus Study)

FT-4202 is designed to activate PKR and thereby modulate RBC metabolism by impacting two critical pathways in RBCs. The FT-4202 clinical development program will investigate whether decreasing 2,3-DPG may help oxygen bind to hemoglobin (i.e. increasing oxygen affinity), and thereby increase ATP and impact RBC function. This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients age 12 to 65 years (inclusive), with sickle cell disease. There are two planned interim analyses in this study design. Initially, patients will be randomized at 1:1:1 to one of two dose levels of FT-4202 or placebo. At the first interim analysis, one of the two FT-4202 dose levels will be selected for the Phase 3 portion of the study, in which patients will be randomized at 1:1 to the selected FT-4202 dose or placebo. Efficacy on hemoglobin will be evaluated at the second interim analysis, and then will be tested along with evaluation of efficacy on vaso-occlusive crises at the final analysis. Following completion of 52 weeks of double-blind treatment, patients may enter a 52-week FT-4202 open-label extension period. **For more information, please visit[ _hibiscusstudy.com_](https://hibiscusstudy.com/?utm_source=CenterWatch&utm_medium=Listing&utm_campaign=Hibiscus).**

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)

For more information, please contact Incyte Corporation at 1.855.463.3463 or visit **[www.incyteclinicaltrials.com](https://www.incyteclinicaltrials.com/)**

A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT and MET. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma (516-003)

Sitravatinib oral capsules administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 weeks. Several laboratory tests will be performed using samples of tumor tissue (archival tissue may be submitted and/or having tumor biopsy performed prior to the study and at 1 timepoint on-study) or blood to understand how and why the drugs may work together in the treatment of urothelial carcinoma. For further information, please contact **Mirati Therapeutic Study Locator Services** via e-mail at [**miratistudylocator@emergingmed.com**](mailto:miratistudylocator@emergingmed.com) or via phone **1-844-893-5530** (toll free).

Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

For more information, please contact Incyte Corporation at 1.855.463.3463

Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components

This is a two-part, Phase 2, double-blind, placebo-controlled, randomized, multicentre study. Subjects with a diagnosis of PD and dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study.

Study of HB-200 alone and with pembrolizumab for patients with Recurrent/ Metastatic HPV 16+ Head and Neck and other Cancers

Integument-1 study

The study drug consists of a cream of the medication or a placebo (same cream without the active drug) that will be applied once daily for 28 days. This treatment is experimental, and you (or your child) will have 1 in 2 chances to be part of the placebo part of the study. At the end of the study, participants may be eligible to participate in the open-labeled study, which would allow the participants to continue to receive the study treatment. More information will be made available to the participants should they be interested. Blood samples will be collected on screening, day 1 and week 4. If you consent to medical photography, it will be performed at day 1, week 1 and week 4. For more information and to register to the study, please visit the study page: http://eczema-study.com/

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)

ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adult Subjects with Recurrent Clostridioides difficile Infection (RCDI)

Approximately 195 subjects with at least two episodes of CDI (including current episode) in the previous 12 months from Screening, a positive C. difficile toxin test result on a stool sample, and who have responded to standard-of-care (SOC) antibiotic treatment will be enrolled. All enrolled subjects will have access to our Investigational Product, SER-109. Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. SERES-013 Cohort 2 is a 24-week study, comprised of three study periods (Screening, Treatment, and Safety Follow Up), with two clinic visits and all other visits can be telephone visits.