Trial studying safety and effects for Gastrointestinal Neoplasms
Official title A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)
ClinicalTrials.gov ID: NCT06885034
What this study is testing
What is Risvutatug Rezetecan?
Risvutatug Rezetecan is an investigational medicine, being studied as a potential treatment for gastrointestinal neoplasms.
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 study will check how well a new medicine, Risvutatug rezetecan, (Ris-Rez, also known as GSK5764227) works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.
- 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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed...
- Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by...
- Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO...
- Is willing to use adequate contraception.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or...
- Has had any major surgery within 28 days prior to randomization or first dose of study intervention, depending on sub-cohort/cohort assignment
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- Has severe, uncontrolled or active cardiovascular disorders.
- Has serious or poorly controlled hypertension.
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF). CRC Cohort
- Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification). PDAC Cohort
- Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification). All Cohorts
- Is willing to use adequate contraception.
- Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Has an ECOG performance status of 0 or 1.
- Has adequate organ function.
- Participants are excluded from the study if any of the following criteria apply:
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast...
- Has had any major surgery within 28 days prior to randomization or first dose of study intervention, depending on sub-cohort/cohort assignment
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- Has severe, uncontrolled or active cardiovascular disorders.
- Has serious or poorly controlled hypertension.
- Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
- Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
- Has evidence of current ILD/non-infectious pneumonitis or a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD/non-infectious pneumonitis that cannot be ruled out by...
- Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.
- Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.
- Is pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Whittier, California, United States
- Aurora, Colorado, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Wenatchee, Washington, United States
- Madison, Wisconsin, United States
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- Bonheiden, Belgium
- Brussels, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Porto Alegre, Brazil
- São Paulo, Brazil
- Teresina, Brazil
+ 55 more site(s).
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 - 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?
Study sites include Los Alamitos, California, United States; Los Angeles, California, United States; Santa Monica, California, United States; Whittier, California, United States; Aurora, Colorado, United States; New York, New York, United States and 69 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.