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A Phase 1/2 Study of AMG 193 in Combination with IDE397 in Subjects with Advanced MTAP-null Solid Tumors
EU CTIS ID: 2023-504364-42-00
What this study is testing
Part 1: To study the maximum tolerated dose (MTD; the highest dose of the study drugs in combination which is safe to take and tolerated) or recommended dose of AMG 193 in combination with IDE397 in adult participants with locally advanced or metastatic MTAP-null solid tumors Part 2: To study the anti-cancer activity of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non Small Cell Lung Cancer (NSCLC).
- 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
- Evidence of homozygous loss of MTAP (null) and/or MTAP deletion
- Presence of advanced/metastatic solid tumor not amenable to curative treatment. For Part 1, MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists. For Part 2, MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
- Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
- Disease measurable as defined by RECIST v1.1
- Adequate organ function as defined in the protocol
- Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.
You likely can't join if
- Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
- Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease
- Cardiovascular and pulmonary exclusion criteria as defined in the protocol
- Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)
- History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
- Prior irradiation to > 25% of the bone marrow
See the full eligibility criteria
- Evidence of homozygous loss of MTAP (null) and/or MTAP deletion
- Presence of advanced/metastatic solid tumor not amenable to curative treatment. For Part 1, MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists. For Part 2, MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
- Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
- Disease measurable as defined by RECIST v1.1
- Adequate organ function as defined in the protocol
- Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.
- Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
- Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease
- Cardiovascular and pulmonary exclusion criteria as defined in the protocol
- Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)
- History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
- Prior irradiation to > 25% of the bone marrow
- Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Australia
- United States
- Taiwan
- Canada
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 Korea, Republic of; Australia; United States; Taiwan; Canada. 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.