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RecruitingLast updated: 2 April 2024

AMG193: This study is assessing how safe, tolerable and effective the combination of two targeted therapy drugs is in people with metastatic or locally advanced MTAP-null solid cancersA 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

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 patients with metastatic or locally advanced MTAP-null solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

AMG193

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Eligibility

Inclusion

  1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
  2. Presence of advanced/metastatic solid tumor not amenable to curative treatment

    1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
    2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
  3. Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
  4. Disease measurable as defined by RECIST v1.1
  5. Adequate organ function as defined in the protocol.
  6. 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

  1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
  2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
  3. Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
  4. 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)
  5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
  6. Prior irradiation to > 25% of the bone marrow
  7. 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

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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