Drugs / Calderasib
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT07222098 | Nov → Dec 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT07219550 | Nov 2025 → Aug 2026 overdue | — | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT06942741 | May → Jun 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06814119 | Apr 2025 → Jan 2026 | impaired renal function disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06575933 | Sep → Oct 2024 | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06687759 | Jun → Aug 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06719557 | May → Jul 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06619314 | Sep → Nov 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT05853367 | Jul 2023 → Jun 2028 expected | metastatic neoplasm, neoplasm | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05067283 | Dec 2021 → Feb 2030 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07286149 | Apr 2026 → Aug 2029 expected | lung cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07252739 | Dec 2025 → Nov 2029 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07209111 | Dec 2025 → Apr 2032 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07554339 | Jun 2026 → Dec 2032 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07431827 | Mar 2026 → Oct 2039 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07190248 | Oct 2025 → Dec 2029 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06997497 | Jul 2025 → Mar 2029 expected | colon adenocarcinoma, rectum adenocarcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06345729 | May 2024 → Jan 2028 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-05-29 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC) merck.com ↗
This is the first Breakthrough Therapy designation for calderasib and was supported by positive data from the Phase 1 KANDLELIT-001 trial. |
| 2025-05-30 | Merck Sharp & Dohme LLC | Results Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today safety and efficacy results from the open-label Phase 1 KANDLELIT-001 study, a clinical trial evaluating MK-1084, an investigational next-generation KRAS G12C inhibitor, alone and in combination with other therapies in certain patients with KRAS G12C-mutant solid tumors, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Calderasib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07222098 ↗ |
| Known as | MK-1084 | “A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)” NCT06942741 ↗4“A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)” NCT06814119 ↗ |
| Action | Inhibit | “Herein, we disclose our journey toward the discovery of MK-1084, an orally bioavailable and low-dose KRASG12C covalent inhibitor currently in phase I clinical trials (NCT05067283).” PMID 38924388 ↗ Jun 2024 |
| Route | Oral | “Participants will receive daily oral escalating doses of up to 800 mg of calderasib until progressive disease or discontinuation.” NCT05067283 ↗ |
| Target | KRAS | “Herein, we disclose our journey toward the discovery of MK-1084, an orally bioavailable and low-dose KRASG12C covalent inhibitor currently in phase I clinical trials (NCT05067283).” PMID 38924388 ↗ Jun 2024 |