A study to evaluate the safety and the activity of S095029 as a part of combination therapy in advanced gastroesophageal junction/gastric cancers
EU CTIS ID: 2023-507995-33-00
What this study is testing
Phase 1b (safety lead in part): To evaluate the safety and tolerability of the combination and to identify the recommended Phase 2 dose (RP2D) of S095029 in combination therapy. Phase 2: - To evaluate the antitumor activity of S095029 in combination therapy - To evaluate the safety and tolerability profile of S095029 in combination therapy
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have a histologically or cytologically confirmed diagnosis of a locally advanced and unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Participants’ tumor must have an MSI-H/dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment. This status may be documented in a report in the participant’s medical history or the MSI-H/dMMR status may be documented by testing archival tumor tissue or tissue from a newly collected tumor biopsy (if no appropriate archived specimen is available).
You likely can't join if
- Has received prior therapy with any checkpoint inhibitor (anti-PD-1, anti-programmed cell death ligand 1 (PDL1), anti-CTLA4).
- Has received more than one previous line of treatment in the locally advanced and unresectable or metastatic setting. Previous treatment line may include trastuzumab and chemotherapy, or doublet/triplet chemotherapy regimens. Note: participants who have received only one cycle of chemotherapy prior to determination of their tumor’s MSI-H status, and who have not yet been treated with an anti-PD-1/L1 agent are not considered to have had one prior line of treatment. Previous treatment with chemotherapy in the neoadjuvant or adjuvant setting is permitted and is not counted as a previous line of therapy for the purpose of determining a patient’s eligibility.
- Participants who have received prior systemic anti-cancer therapy including investigational agents within 4 weeks (shorter interval, at least 5 half-lives, for kinase inhibitors or other short half-life drugs), prior to first study treatment.
- Prior radiotherapy if completed less than 2 weeks before first study treatment or have had a history of radiation pneumonitis. Participants who have not recovered from all radiation-related toxicities and require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
- Major surgery less than 4 weeks prior to the first study treatment or participants who have not recovered from the side effects of the surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Korea, Republic of
- United States
- Canada
- 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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Korea, Republic of; United States; Canada; Japan. 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 EU CTIS; the study team decides eligibility.