RightFit
RecruitingPhase 1 / Phase 2

Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests RAS(ON) inhibitors with ivonescimab in adults with solid tumors that have grown nearby or spread and have a RAS gene change. It checks safety, how well people handle the drugs, how the drugs move through the body, and early signs that they work against cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 and agree to join after learning about the study.
  • Be fully active or able to do light work, with limits on hard physical activity.
  • Have a solid tumor confirmed by a tissue test that has grown nearby or spread, with a KRAS, HRAS, or NRAS gene change.
  • For Part 1: Have cancer that worsened after standard treatment, or have been unable to handle that treatment.
  • For Part 2, Arms A and B: Have non-squamous non-small cell lung cancer, a type of lung cancer, with no treatable cancer-driving change in other genes. Have had no treatment that travels through the body.
  • For Part 2, Arm C: Have a solid tumor, including colon or rectal cancer, treated with no more than 2 courses of treatment for advanced cancer. Cancer must have worsened after standard treatment, or you could not handle it.
  • Have cancer that can be measured using the study's rules.
  • Have good enough bone marrow, liver, kidney, blood-clotting, and hormone function, and be able to take medicine by mouth.

Who can't join

  • Have squamous cell cancer of the head or neck.
  • Have a condition that could affect your ability to take or absorb the study drug.
  • Have had major surgery within 4 weeks before starting the study drugs.
  • Be unable or unwilling to follow the required study visit and procedure schedule.
  • Other rules for joining or being excluded may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. 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.

Study sites (9)

CA

CT

MN

TN

TX

VA