A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103)
A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors
Sponsor: GlaxoSmithKline
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Confirmed Objective Response Rate (cORR)
Time frame: Up to approximately 143 weeks
Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity
Time frame: Up to approximately 143 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 130 weeks
Number of participants with changes in safety parameters
Time frame: Up to approximately 143 weeks
Secondary Endpoints
Progression-free survival (PFS)
Disease control rate at 12 weeks (DCR12)
Duration of Response (DoR)
Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Male or female participants at least 18 years of age (≥18 years) at the time of signing the informed consent form (ICF). * Participants with histologically confirmed advanced/metastatic solid tumors, irrespective of mutational status, as defined per cohort, as follows: ES-SCLC 1. 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) 2. ES-SCLC \[per Veterans Administration Lung Study Group (VALG) criteria\] at study entry Squamous NSCLC or non-squamous NSCLC 3. Histologically or cytologically confirmed Squamous or Non-squamous NSCLC. 4. Metastatic NSCLC (Stage IV), according to American Joint Committee on Cancer (AJCC) 8th edition, * Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. Measurable lesions that ha…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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