A Phase I/II Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors
Study Identifier:
RMC-APEX-103
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.
As per ctis:
• To evaluate the safety and tolerability of RAS(ON) inhibitors in combination with ivonescimab in patients with advanced RAS-mutated solid tumors • To define the RP2D for RAS(ON) inhibitors in combination with ivonescimab, with or without other anti-cancer agents, in patients with advanced RAS-mutated solid tumors
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS. * Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration). * Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A & B for Part 2 Dose Expansion). * Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion). * Measurable disease per RECIST v1.1 * Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine). * Able to take oral medications.
- as per ctis:
- Participants may be included in the study if they • are at least 18 years old. • have a RAS-mutated cancer that has spread or cannot be removed by surgery and at least one tumor that can be measured by scans. Some parts of the study are only open to participants with a specific RAS mutation type. • have adequate organ function.
Exclusion criteria
- Head and neck squamous cell carcinoma. * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 4 weeks prior to receiving study drug(s). * Patient is unable or unwilling to comply with protocol-required study visits or procedures. * Other inclusion/exclusion criteria may apply.
- as per ctis:
- Participants cannot be included in the study if they • have previously received certain medicines that directly target RAS, or certain immune or anti-VEGF therapies (cancer treatment that stops tumors from growing new blood vessels). • have any medical condition including a bleeding issue, or active infections that may interfere with the study medicine. • are pregnant or breastfeeding. • depending on the part of the study, participants may or may not have received previous treatment for their cancer.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Solid Tumor
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Solid Tumor
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Solid Tumor