This is an early-phase clinical study investigating a new combination treatment, Risvutatug rezetecan (Ris-Rez) given with ivonescimab for adults with advanced solid cancers. The study aims to determine:
* What dose(s) of Ris-Rez given with ivonescimab is safe and what are the side effects? * How does the body handle the drug(s)? * What dose of Ris-Rez given with ivonescimab may work best and can improve the treatment of cancer?
Male or female participants at least 18 years of age (≥18 years) at the time of signing the informed consent form (ICF).
Histologically or cytologically confirmed SCLC (prior pathological diagnosis of complex SCLC [such as mixed SCLC and NSCLC] or transformed SCLC [NSCLC to SCLC] is not allowed)
ES-SCLC [per Veterans Administration Lung Study Group (VALG) criteria] at study entry Squamous NSCLC or non-squamous NSCLC
Histologically or cytologically confirmed Squamous or Non-squamous NSCLC.
Has symptomatic Central Nervous System (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to first dose, potential need for CNS radiation within the first cycle, or leptomeningeal disease. Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).
QTc >450 msec or QTc >480 msec for participants with bundle branch block.
Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval >250 msec).
Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval.
Sequential
Risvutatug rezetecan
Biological/VaccineRisvutatug rezetecan will be administered
Ivonescimab
Biological/VaccineIvonescimab will be administered
Phase 1 and Phase 2 Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs)
Phase 1 and Phase 2: Number of participants with AEs leading to dose modifications including study intervention discontinuation
Phase 2: Number of participants with AEs leading to dose modifications or study intervention discontinuation
Phase 1 and Phase 2: Number of participants with changes in safety parameters
Phase 1: Maximum observed plasma concentration (Cmax) of Ris-Rez, rezetecan and ivonescimab
Phase 1: Time to reach maximum concentration (Tmax) of Ris-Rez, GSK5757810 and ivonescimab
Phase 1: Area under the curve (AUC) of Ris-Rez, GSK5757810 and ivonescimab
Phase 1: Trough concentration (Ctrough) of Ris-Rez, GSK5757810 and ivonescimab
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