Neoplasms, Lung study: Risvutatug rezetecan vs Ivonescimab
Official title A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103)
ClinicalTrials.gov ID: NCT07602855
What this study is testing
What is Risvutatug rezetecan?
Risvutatug rezetecan is an investigational medicine, being studied as a potential treatment for neoplasms, lung.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Histologically or cytologically confirmed SCLC (prior pathological diagnosis of complex SCLC [such as mixed SCLC and NSCLC] or transformed SCLC...
- 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.
You likely can't join if
- Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to baseline status preceding prior therapy (excluding...
- Has symptomatic Central Nervous System (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7...
- 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...
- Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of...
- Left Ventricular Ejection Fraction (LVEF) \<50%.
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- Left Ventricular Ejection Fraction (LVEF) \<50%.
- Has severe, uncontrolled or active CV disorders
- Serious or poorly controlled hypertension; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose
- Hemoptysis (defined as coughing up ≥ 1 teaspoon of fresh blood or small blood clots)
- Transient hemoptysis associated with diagnostic bronchoscopy is allowed.
- Nasal bleeding/epistaxis (bloody nasal discharge is allowed)
- Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to first dose is not allowed.
- Participants with a history of esophageal or gastric varicose vein, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute...
- History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 6.0, hypertensive...
- Serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with IV antibiotics for ≥ 2 weeks
- Any evidence of current Interstitial Lung Disease (ILD)/non-infectious pneumonitis OR a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids OR suspected ILD/non-infectious pneumonitis...
- Participants with moderate to severe pulmonary disease or current clinically significant pulmonary compromise that, in the investigator's judgment, could jeopardize safety or study conduct.
- History of allergy or hypersensitivity to Ris-Rez (antibody-drug conjugate (ADC), antibody, payload [GSK5757810]).
- Has received prior anticancer therapy within 14 days of the first dose of study intervention or having to continue these medications during the study.
- History of local radiotherapy within 2 weeks prior to the first dose of study intervention; more than 30% of bone marrow irradiation or extensive radiotherapy within 4 weeks before the first dose of study intervention
- Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage...
- Has received immunosuppressive agents within 30 days prior to first dose of study treatment (or requires long-term (30 days or longer) glucocorticoid therapy).
- Participant with history of nephrotic syndrome or Grade 3 proteinuria or protein urine \>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.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Wilson, North Carolina, United States
- Canton, Ohio, United States
- Osaka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Wilson, North Carolina, United States; Canton, Ohio, United States; Osaka, Japan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.