A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

Korábbi kezelés

• Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
• 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.

Más betegség

• Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic 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 (eg, Crohn's disease, ulcerative colitis)
• History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.

Egyéb

• Cardiovascular and pulmonary exclusion criteria as defined in the protocol.

• 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.