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Not Yet Recruiting NCT07602855

A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103)

Conditions: Neoplasms, Lung

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 184
Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Osaka

Summary

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?

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 * 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. * 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 have been previously irradiated and have been shown to be progressing following irradiation may be considered as TLs. * Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose. * Has a life expectancy of ≥ 3 months with ability to complete at least 4 cycles of study intervention. * Has adequate organ function * Is willing to use adequate contraception (contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies). * For dose expansion only: Tumor tissue (archival tumor tissue or a fresh biopsy) is required for all participants at screening. Tissue from a newly obtained fresh biopsy is preferred. If it is not feasible to obtain a fresh biopsy at screening, archival tumor tissue, (from the most recent biopsy (within 1 year), Formalin Fixation and Paraffin Embedding FFPE) block (preferred), or freshly cut slides is acceptable. If archival tissue is unavailable and it is not medically feasible to obtain fresh tissue, the medical monitor should be informed and exemption to the tissue requirement may be granted on a case-by-case basis. Tumor tissue is necessary for retrospective detection of B7 homolog 3 protein (B7-H3) expression and other biomarker analysis Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: • Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to baseline status preceding prior therapy (excluding alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 1 neuropathy). Has had major surgical procedures or serious trauma within 4 weeks prior to first dose, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator), or minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to first dose. * 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). * Has any of the following: * 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. * Left Ventricular Ejection Fraction (LVEF) \1+ on dipstick or 24-h urine protein quantitation ≥ 1.0 g at Screening. * History of abdominal or gastrointestinal fistula, tracheoesophageal fistula or any Grade 4 fistula, gastrointestinal perforation, or intra-abdominal abscess. * Has any active renal condition (e.g., requirement for dialysis, or any other significant renal condition that could affect the participant's safety). Renal obstruction successfully managed by stenting is permitted.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07602855). StuddyBuddy aggregates publicly available trial information.