Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
The study has two parts: Part 1 (Dose Exploration) and Part 2 (Dose Expansion).
Experimental Part 1:
In this part, participants will receive escalating doses of AMG 193 and IDE397, which will both be administered orally in cycles of 21 days, until the maximum tolerated dose (MTD) or recommended combination dose is determined.
Experimental Part 2:
Participants will receive AMG 193 and IDE397 which will be both administered orally in cycles of 21 days
Conditions
This trial is treating people with metastatic or locally advanced MTAP-null solid cancers
Eligibility
Inclusion
- Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
-
Presence of advanced/metastatic solid tumor not amenable to curative treatment
- Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
- 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.
Exclusion
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Amgen
Scientific Title
A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors
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