Drugs / Tunlametinib

Trials 20 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT04683354 Dec 2020 → Sep 2022 cancer Kechow Pharma, Inc. Completed No outcome recorded
Phase 1 NCT03990077 May 2020 → Jul 2021 non-small cell lung carcinoma Shanghai Kechow Pharma, Inc. Terminated No outcome recorded
Phase 1 NCT03976050 Jun 2019 → Nov 2020 cancer Shanghai Kechow Pharma, Inc. Terminated No outcome recorded
Phase 1 NCT03781219 Jul 2018 → Dec 2023 neoplasm Shanghai Kechow Pharma, Inc. Unknown No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03973151 Sep 2017 → Jan 2021 melanoma Shanghai Kechow Pharma, Inc. Completed No outcome recorded
Phase 210 trials
Phase 2 NCT07170293 Aug → Sep 2027 expected solid adenocarcinoma with mucin production Tianjin Medical University Second Hospital Recruiting No outcome recorded
Phase 2 NCT07507526 Apr 2026 → Apr 2028 expected gastric adenocarcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07463677 Mar 2026 → May 2028 expected non-small cell lung carcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07446270 Mar 2026 → Oct 2027 expected colorectal cancer Chinese PLA General Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06970353 May 2025 → Dec 2026 expected thyroid cancer, nonmedullary, 3 Fudan University Recruiting No outcome recorded
Phase 2 NCT05900219 Sep 2023 → Sep 2025 non-small cell lung carcinoma Shanghai Kechow Pharma, Inc. Unknown No outcome recorded
Phase 2 NCT05233332 Feb 2022 → Jan 2024 Shanghai Kechow Pharma, Inc. Unknown No outcome recorded
Phase 2 NCT05331105 Oct 2021 → Oct 2025 overdue neurofibromatosis type 1, plexiform neurofibroma Shanghai Kechow Pharma, Inc. Recruiting No outcome recorded
Phase 2 NCT05263453 Sep 2021 → Sep 2024 melanoma Shanghai Kechow Pharma, Inc. Unknown No outcome recorded
Phase 2 NCT05217303 Nov 2020 → Feb 2023 melanoma Shanghai Kechow Pharma, Inc. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT06008106 Nov 2023 → Sep 2027 expected melanoma Shanghai Kechow Pharma, Inc. Recruiting No outcome recorded
Phase 3 NCT06008119 Oct 2023 → Dec 2026 expected colorectal cancer Shanghai Kechow Pharma, Inc. Recruiting No outcome recorded
Phase 42 trials
Phase 4 NCT07445022 Jan 2026 → Sep 2028 expected melanoma Fudan University Recruiting No outcome recorded
Phase 4 NCT07302841 Jan 2026 → Jun 2027 expected pancreatic neoplasm Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase not applicable1 trial
NCT06985316 May 2025 → Apr 2028 expected colorectal cancer Liu Huang Not yet recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT07714447 Background Nov 2026 → Feb 2029 expected colorectal cancer Sun Yat-sen University Not yet recruiting No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as Tunlametinib Tunlametinib: 9 mg per dose, administered orally twice daily (BID).” NCT07714447
11

Tunlametinib (HL-085) is a novel, highly selective MEK inhibitor” PMID 38867257 Jun 2024

NCT07302841

NCT06985316

NCT06008106

NCT07170293

NCT07463677

NCT07507526

NCT06970353

NCT07446270

NCT06008119

NCT07445022

Known as HL-085 “observing and evaluating the efficacy and safety of Tunlametinib (HL-085) in the treatment of refractory solid tumors” NCT07170293
10

“Tunlametinib (HL-085) is a novel, highly selective MEK inhibitor” PMID 38867257 Jun 2024

NCT05900219

NCT05233332

NCT05217303

NCT05263453

NCT03990077

NCT04683354

NCT03976050

NCT03973151

NCT05331105

Action Inhibit “Tunlametinib (HL-085) is a novel, highly selective MEK inhibitor” PMID 38867257 Jun 2024
Modality Small molecule CHEMBL5095241
Route Oral orally administered” PMID 36600247 Jan 2023