Clinical Trials List
Protocol NumberMK-1084-001
NCT Number(ClinicalTrials.gov Identfier)NCT05067283
Active
2023-08-10 - 2026-12-31
Phase I
Recruiting3
ICD-10C78.5
Secondary malignant neoplasm of large intestine and rectum
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9197.5
Secondary malignant neoplasm of large intestine and rectum
A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 廖斌志 無
- Jih-Hsiang Lee 無
- Chong-Jen Yu 無
- YEN-TING LIN 無
- 陳國興 無
- Kun-Huei Yeh 無
- 楊景堯 無
- 廖唯昱 無
- 林昭文 Division of Ophthalmology
- 梁逸歆 無
- CHAO-CHI HO CHAO-CHI HO 無
- 許嘉林 無
- 吳尚俊 無
- 徐偉勛 無
- James Chih-Hsin Yang 無
- JIN-YUAN SHIH 無
- 蔡子修 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Jui Yen
- Chun-Hui Lee
- Shang-Hung Chen
- Jui-Hung Tsai
- 黃盈慈
- Po-Wen Lin Division of General Surgery
- Peng-Chan Lin
- 顏志傑
- 蘇勇曄
- Shang-Yin Wu
- Chien-Chung Lin
- 黃怡璇 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
Determining the safety and tolerability of MK-1084 in monotherapy and as part of combination therapy
Test Drug
MK-1084 Gisuda Injection
Active Ingredient
MK-1084
MK-1084
Pembrolizumab
MK-1084
Pembrolizumab
Dosage Form
Tablet
Ingection
Ingection
Dosage
25mg, 100mg
25mg, 50mg
25 mg/mL
25mg, 50mg
25 mg/mL
Endpoints
‧ Dose-limiting toxicity (DLT)
‧ Adverse events (AE)
‧ Test suspension due to AE
‧ Adverse events (AE)
‧ Test suspension due to AE
Inclution Criteria
Inclusion Criteria:
For all participants:
Has measurable disease by RECIST 1.1 criteria
Has adequate organ function
Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic
Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
For Arm 2
- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
For Arm 3
Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 3L/4L metastatic colorectal cancer (mCRC)
Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation
Previous treatment failure of 2 or 3 previous lines of systemic therapy Expansion Group B
Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
Arm 5 only
Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
Previous treatment failure of one or 2 previous line(s) of systemic therapy
Arm 6 only
- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
For all participants:
Has measurable disease by RECIST 1.1 criteria
Has adequate organ function
Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic
Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
For Arm 2
- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
For Arm 3
Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 3L/4L metastatic colorectal cancer (mCRC)
Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation
Previous treatment failure of 2 or 3 previous lines of systemic therapy Expansion Group B
Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
Arm 5 only
Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
Previous treatment failure of one or 2 previous line(s) of systemic therapy
Arm 6 only
- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
Exclusion Criteria
Exclusion Criteria:
Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention
Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy
Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
Has an active autoimmune disease requiring systemic therapy
Has not fully recovered from any effects of major surgical procedure without significant detectable infection
Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease
Has received live or live-attenuated vaccine within 4 weeks of study start
Arm 4 Only
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention
Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy
Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
Has an active autoimmune disease requiring systemic therapy
Has not fully recovered from any effects of major surgical procedure without significant detectable infection
Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease
Has received live or live-attenuated vaccine within 4 weeks of study start
Arm 4 Only
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
The Estimated Number of Participants
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Taiwan
18 participants
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Global
830 participants
