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A phase 1/1b/2 study of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors.
EU CTIS ID: 2023-504363-17-00
What this study is testing
Part 1 and 2: To evaluate the safety, tolerability, and to determine the MTD or RP2D of AMG 193 alone and in combination with docetaxel in adult subjects with metastatic or locally advanced MTAP-null solid tumor. Part 3: To evaluate the efficacy of AMG 193 in adult subjects with metastatic or locally advanced MTAP-null solid tumors.
- Phase I and Phase II (Integrated)- First administration to humans
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 CDKN2A (null) and/or MTAP (null) by NGS or central IHC
- Adequate cardiac function.
- Age ≥ 18 years
- Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
- Able to swallow and retain PO administered study treatment and willing to record daily adherence to investigational product.
- Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
You likely can't join if
- Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
- Spinal cord compression or untreated brain metastases or leptomeningeal disease.
- Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease.
- History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before study entry.
- Prior irradiation to > 25% of the bone marrow.
- Use of prescription medications that are known strong inducers or inhibitors of CYP3A4 within 14 days or 5 half-lives before study day 1.
See the full eligibility criteria
- Evidence of homozygous loss of CDKN2A (null) and/or MTAP (null) by NGS or central IHC
- Adequate cardiac function.
- Age ≥ 18 years
- Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
- Able to swallow and retain PO administered study treatment and willing to record daily adherence to investigational product.
- Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Adequate hematopoietic function.
- Adequate renal function.
- Adequate liver function.
- Adequate pulmonary function.
- Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
- Spinal cord compression or untreated brain metastases or leptomeningeal disease.
- Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease.
- History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before study entry.
- Prior irradiation to > 25% of the bone marrow.
- Use of prescription medications that are known strong inducers or inhibitors of CYP3A4 within 14 days or 5 half-lives before study day 1.
- Major surgery within 28 days before first dose of AMG 193
- Evidence of Hepatitis B or C infection
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Taiwan
- China
- United Kingdom
- Switzerland
- Japan
- United States
- Australia
- Hong Kong
- 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; Taiwan; China; United Kingdom; Switzerland; Japan and 4 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 EU CTIS; the study team decides eligibility.