Saint Lô, France

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies

This is an open-label, multicenter, phase I study of PIT565 in patients with R/R B-NHL and R/R B-ALL. The study comprises a dose escalation part of PIT565 in two independent groups (group A: R/R B-NHL and B: R/R B-ALL) and a dose expansion part in three independent groups (R/R large B-cell lymphoma (LBCL) randomized in 1:1 ratio to two RDs (A1 and A2), and R/R B-ALL (B1)). During the dose escalation, the safety (including the dose-dose limiting toxicity (DLT) relationship) and tolerability of PIT565 will be assessed, and schedule(s), route(s) of administration and dose(s) will be identified for use in the expansion part based on the review of these data. The RD will also be guided by the available information on pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity. The dose escalation will be guided by an adaptive Bayesian logistic regression model (BLRM) following the Escalation with Overdose Control (EWOC) principle. Different schedules and routes of administrations will be explored in the dose escalation groups. The dose expansion will further explore the MTD(s) and/or RD(s) and the selected schedule(s) and route of administration(s) in the three patients' groups.

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

This is a multicentre, Phase III, randomised, open-label study to investigate the efficacy and safety of savolitinib administered orally in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with osimertinib as the most recent therapy. Approximately 324 participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC will be randomly assigned to study intervention with 1:1 ratio. Patients will be treated until either objective progression of disease (PD) by Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn, or another discontinuation criterion is met.

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients with HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma

This study is an open-label, single-arm, multicenter, phase 2 clinical trial. Eligible patients are with previously untreated gastric and gastroesophageal junction adenocarcinoma as defined by cT2-4 and/or cN+ without evidence of metastatic disease. Study treatment in this study is neoadjuvant treatment with the investigational drug, T-DXd alone, followed by surgery. T-DXd will be administered at a dose of 6.4 mg/kg (decimal) by intravenous infusion every 21 days (3 weeks) for 3 cycles as the neoadjuvant treatment followed by surgery. In the combination cohort, the efficacy and safety of neoadjuvant chemotherapy combined with T-DXd, capecitabine, and durvalumab are evaluated. T-DXd 5.4 mg/kg and Durvalumab 1500 mg were infused intravenously once 3 weeks, and Capecitabine 750 mg/m2 was administered orally twice daily for 14 days with a 7-day rest period. T-DXd, Capecitabine, and Durvalumab were repeated 3 cycles preoperatively and 3 cycles postoperatively, followed by 10 cycles of Durvalumab monotherapy every 4 weeks. Monotherapy will be analyzed in the following 2 analysis sets. - Patients with HER2 overexpression (IHC3+ or IHC2+ and ISH-positive [FISH or DISH]) in the primary lesion or metastasis (primary analysis part) - Patients with low expression of HER2 (IHC1+ or IHC2+ and negative for ISH [FISH or DISH]) and HER2-ECD > 11.6 ng/mL in the primary lesion or metastasis (exploratory part) The combination cohort will be analyzed in the following analysis sets. - Patients with HER2 overexpression (IHC3+ or IHC2+ and ISH-positive [FISH or DISH]) in the primary lesion or metastasis with gastric adenocarcinoma or GEJ adenocarcinoma

A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).