Recoleta

Researchers are evaluating the safety and preliminary effectiveness of SAR445877, given alone or with other anticancer treatments, in adults aged 18 and older who have advanced, hard-to-remove, or metastatic solid tumors. This Phase 1/2 study includes multiple groups and aims to find appropriate doses and understand how well the treatment works, including combinations with cetuximab, ADG126, or bevacizumab. The study involves about 542 participants, including those in a Japan-specific group, reflecting a wide range of advanced solid tumor types. The study has two main parts. Part 1 focuses on dose escalation to identify safe and effective doses of SAR445877 given either every two weeks or weekly, alone or combined with other therapies. Part 2 involves expanding and optimizing doses to assess safety and early effectiveness in various tumor types and treatment combinations. Participants receive SAR445877 and other drugs by infusion. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping treatment. Participants will undergo screening for up to 28 days before starting treatment, then receive ongoing therapy with regular monitoring. Assessments include scans and tests to measure tumor response, safety evaluations for side effects including dose-limiting toxicities, and follow-up visits after treatment ends. The study tracks outcomes during treatment cycles and for up to two years in the expansion phase, with safety follow-up lasting 30 days after the last dose. Overall, the participation duration varies depending on individual course and response.

Researchers are conducting a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab with investigator's choice monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who have incurable metastatic or recurrent disease. This study focuses on patients with progressive disease after anti-PD-1 therapy and platinum-containing therapy and aims to evaluate the treatments as second- or third-line options. Participants will receive either petosemtamab or one of the investigator's choice monotherapies, including cetuximab, methotrexate, or docetaxel. The study involves treatment administration under controlled conditions with monitoring for efficacy and safety. The goal is to assess the treatments over time with a focus on response rates and overall survival. During the study, participants will undergo regular assessments including radiologic imaging to measure tumor response, and evaluations of overall survival up to approximately three years. The primary outcomes include objective response rate assessed by blinded independent central review and overall survival. Researchers will monitor patient health, side effects, and treatment effectiveness throughout the study duration.

Researchers are evaluating the safety and effectiveness of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as a first treatment for people with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease, though prior therapy for locally advanced disease is allowed under certain conditions. The study excludes patients who have been treated with anti PD-(L)1 or anti-EGFR therapies except in specific cases. Participants will receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone as their first-line treatment for this condition. The study includes detailed eligibility criteria based on tumor location, PD-L1 expression, health status, and prior treatments. Treatment effects will be observed over time with a focus on overall survival and tumor response rates measured according to standard criteria. During the study, participants will undergo assessments including tumor biopsies, imaging scans to measure disease progression, heart function tests, and evaluations of organ function. Safety and treatment response will be closely monitored up to approximately three years. The study also tracks overall survival and tumor response rate as primary outcomes, ensuring continuous follow-up and support throughout the trial period.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

This research aims to evaluate the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with previously untreated, unresectable, or metastatic colorectal cancer. The study is a blinded, randomized Phase 2/3 trial targeting participants with histologically confirmed recurrent or metastatic colorectal adenocarcinoma that cannot be cured with surgery. Participants must not have certain genetic markers such as mismatch repair deficiency, microsatellite instability-high status, or BRAF V600E mutation. Participants will receive either pumitamig or bevacizumab along with chemotherapy regimens including FOLFOX, FOLFIRI, or CAPOX at specified doses and schedules. The interventions involve administering these drugs on specified days, though exact dosing details are not provided. The study compares these two treatment combinations to assess their safety and efficacy in this patient population. Throughout the study, participants will be monitored for tumor response using RECIST v1.1 criteria, progression-free survival, and overall survival for up to five years. Researchers will evaluate confirmed complete or partial tumor responses, survival rates, and disease progression. The study includes regular assessments to track treatment effects and safety over a long-term follow-up period, ensuring comprehensive monitoring of participant outcomes.

Researchers are evaluating whether zongertinib, an oral medication targeting HER2 mutations, can improve outcomes compared to standard adjuvant treatments in adults with completely removed Stage II to IIIB non-small cell lung cancer (NSCLC) with activating HER2 tyrosine kinase domain mutations. Participants must have had surgery intended to cure the cancer and received standard systemic therapy around the time of surgery, including neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. This global, open-label Phase 3 study aims to assess if zongertinib can extend the time participants remain free from disease. After surgery and necessary systemic therapy, participants are randomly assigned to one of two groups. One group receives zongertinib orally once daily for up to three years. The other group receives standard care, which may include approved adjuvant immunotherapy drugs such as pembrolizumab, atezolizumab, durvalumab, or nivolumab, or observation depending on local medical practices and patient status. This comparison allows researchers to evaluate zongertinib against current treatment standards. Participants will be monitored regularly to assess disease-free survival over a period of up to eight years and five months. Researchers also evaluate overall survival, safety, tolerability, and patient-reported outcomes throughout the study. Tumor samples are collected to confirm HER2 mutation status, and participants' health and organ function are regularly assessed to ensure safety during the trial.

Researchers are evaluating adults with advanced small cell lung cancer (SCLC) in this study. The main goal is to see if adding a medicine called obrixtamig to the usual treatment, which includes atezolizumab, carboplatin, and etoposide, helps patients live longer compared to the usual treatment alone. Obrixtamig is an antibody-like drug that may support the immune system in fighting cancer. The study also tests a new medical device designed to measure levels of a tumor marker called DLL3. Participants are randomly assigned to one of two groups. One group receives obrixtamig along with the standard treatment, while the other group gets only the standard treatment. All medicines are given through a vein. Those receiving obrixtamig must stay overnight at the study site after their first two treatments with this medicine. Treatment continues as scheduled, following the same general approach for both groups. During up to three years of participation, patients regularly visit the study site for tumor size assessments and health checks. Researchers monitor side effects and compare the results between the two groups to determine treatment effectiveness. The main outcome measured is overall survival over this period.

Researchers are evaluating the efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.

Researchers are evaluating the effectiveness of saruparib (AZD5305) combined with camizestrant compared to physician's choice of CDK4/6 inhibitor plus endocrine therapy or plus camizestrant in patients with advanced breast cancer. Participants must have hormone receptor-positive, HER2-negative breast cancer with specific genetic mutations in BRCA1, BRCA2, or PALB2. This is a phase III randomized, open-label study focused on first-line treatment for this patient group. Participants will be randomly assigned in a 2:2:1 ratio to one of three treatment groups: saruparib plus camizestrant; physician's choice of CDK4/6 inhibitor plus physician's choice of endocrine therapy; or physician's choice of CDK4/6 inhibitor plus camizestrant. Treatment continues until disease progression confirmed by blinded independent central review, unacceptable side effects occur, or the participant decides to stop. During the study, about 500 participants will be monitored for progression-free survival for up to approximately 59 months. Researchers will collect tissue samples and assess organ function, performance status, and treatment safety. Participants will be evaluated regularly for disease progression, treatment tolerability, and overall health throughout the study duration.

Researchers are evaluating the efficacy, safety, and tolerability of adding subcutaneous lunsekimig compared with placebo as treatment for adults aged 18 to 80 with high-risk asthma who currently do not qualify for biologic therapies. This Phase 2, randomized, double-blind, placebo-controlled study focuses on participants with mild-to-moderate asthma diagnosed for over a year, who have had at least one asthma exacerbation in the previous year. The goal is to better understand lunsekimig's effects in this specific asthma population. Participants will be randomly assigned to receive either subcutaneous injections of lunsekimig or placebo over approximately 52 weeks. Alongside this, they may continue using other asthma medications such as various inhaled treatments including fluticasone/salmeterol, budesonide/formoterol, budesonide/albuterol, or short-acting beta agonists. The study includes up to 18 visits throughout the treatment period, with some participants possibly continuing into a long-term safety (LTS) study lasting up to 60 weeks total. During the study, participants will undergo regular assessments to monitor asthma control, lung function, and the rate of asthma exacerbations. The primary measurement is the annualized rate of asthma exacerbation events from baseline up to 52 weeks. Safety and tolerability will also be closely observed. The total study duration for most participants will be around 64 weeks if they do not enter the LTS study. Researchers will gather data through clinical visits, lung function tests, and ongoing safety monitoring to evaluate the treatment's impact and participant health throughout the trial.