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NCT06270082
Study of IK-595 in RAS- or RAF-altered Advanced Tumors
Phase 1 trial testing IK-595 in Solid Tumor, Adult in 75 participants. Terminated before completion.
8 September 2025
Quick facts
| Lead sponsor | Ikena Oncology |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 18 December 2023 |
| Primary completion | 8 September 2025 |
| Estimated completion | 8 September 2025 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- IK-595 — full drug profile →
Conditions studied
- Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
- Malignant Melanoma — all drugs for Malignant Melanoma →
Sponsor
Ikena Oncology — full company profile →
Who can join
18 and older, any sex, with Solid Tumor, Adult or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exploring treatment options in cancer: Tumor treatment strategies.
Liu B, Zhou H, Tan L, Siu KTH, et al · · 2024 · cited 536× · PMID 39013849 · DOI 10.1038/s41392-024-01856-7 -
Kinase Inhibitors and Kinase-Targeted Cancer Therapies: Recent Advances and Future Perspectives.
Li J, Gong C, Zhou H, Liu J, et al · · 2024 · cited 54× · PMID 38791529 · DOI 10.3390/ijms25105489 -
Targeting the KRAS Oncogene for Patients with Metastatic Colorectal Cancer.
Miao R, Yu J, Kim RD. · · 2025 · cited 8× · PMID 40361439 · DOI 10.3390/cancers17091512 -
<i>KRAS</i>, a New Target for Precision Medicine in Colorectal Cancer?
Boilève A, Smolenschi C, Lambert A, Boige V, et al · · 2024 · cited 5× · PMID 39456549 · DOI 10.3390/cancers16203455 -
Targeted protein degradation with small molecules for cancer immunotherapy.
Yang Z, Xu J, Yang X, Chen J. · · 2025 · cited 3× · PMID 40791660 · DOI 10.1016/j.ajps.2025.101058 -
Navigating Therapeutic Challenges in BRAF-Mutated NSCLC: Non-V600 Mutations, Immunotherapy, and Overcoming Resistance.
Bortolot M, Torresan S, De Carlo E, Bertoli E, et al · · 2024 · cited 2× · PMID 39684685 · DOI 10.3390/ijms252312972 -
Emerging Therapeutic Approaches to Pancreatic Adenocarcinoma: Advances and Future Directions.
Peng C, Oberstein PE. · · 2025 · cited 1× · PMID 40884689 · DOI 10.1007/s11864-025-01352-2 -
Anticancer drug therapy for anaplastic thyroid cancer.
Kiyota N, Koyama T, Sugitani I. · · 2025 · cited 1× · PMID 40163699 · DOI 10.1530/etj-24-0287
Verify or expand the search:
- PubMed search for NCT06270082
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumor, Adult
Currently open trials in the same condition.
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- NCT06398418 — R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients · Phase 1 · recruiting
- NCT06682793 — A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumor · Phase 1, PHASE2 · recruiting
- NCT07137195 — Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei) · NA · active not recruiting
- NCT06714617 — Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
Other Ikena Oncology trials
Trials by the same sponsor.
- NCT05228015 — Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors · Phase 1 · terminated
- NCT04682431 — A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors · Phase 1 · terminated
- NCT04691375 — A Study of PY314 in Subjects With Advanced Solid Tumors · Phase 1 · terminated
- NCT04200963 — A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Me · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06270082 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ikena Oncology
- Last refreshed: 19 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06270082.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing