MedTrace Logo

Study of IK-595 in RAS- or RAF-altered Advanced Tumors

NCT06270082 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit.

Conditions

  • Solid Tumor, Adult
  • Colorectal Cancer
  • Pancreatic Cancer
  • Malignant Melanoma
  • Ras (Kras or Nras) Gene Mutation
  • BRAF Gene Mutation
  • CRAF Gene Mutation
  • Non-Small Cell Lung Carcinoma
  • Thyroid Carcinoma
  • Gliomas, Malignant

Interventions

DRUG

IK-595

Oral tablet administered in 28-day or 30-day cycles until treatment discontinuation criteria are met.

Sponsors & Collaborators

  • Ikena Oncology

    lead INDUSTRY

Principal Investigators

  • Caroline Germa, MD · Ikena Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2025-09-08
Completion
2025-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270082 on ClinicalTrials.gov