18 and older, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1Primary· 28 days
Toxicities were graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Any of the following events considered to be causally related to treatment with mocetinostat in combination with durvalumab that occurred during Phase 1 were considered a DLT:
* Any Grade 4 immune-related adverse event (irAE)
* Grade 3 or greater colitis
* Grade 3 or greater noninfectious pneumonitis
* Grade 2 pneumonitis that did not resolve to ≤ Grade 1 within 3 days of the initiation of maximal supportive care
* Grade 3 irAE (excluding colitis or pneumonitis) t
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
0
Phase 1: Dose Escalation - 70 mg
0
Phase 1: Dose Escalation - 90 mg
0
Objective Response Rate (ORR)Primary· Up to approximately 10 months
Objective Response Rate (ORR) was defined as the number of participants documented to have a confirmed Complete Response (CR) or Partial Response (PR). Complete Response was defined as the complete disappearance of all target lesions with the exception of nodal disease. Partial Response was defined at least a 30% decrease in the sum of diameters of target measurable lesions. Responses were determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Participants without response data were counted as non-responders.
Inferential statistical analyses were conduct
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
0
0.0 – 52.2
Phase 1: Dose Escalation - 70 mg
0
0.0 – 60.2
Phase 1: Dose Escalation - 90 mg
0
0.0 – 33.6
Phase 2: Combination Regimen - Cohort 1
6.7
0.2 – 31.9
Phase 2: Combination Regimen - Cohort 2
0
0.0 – 70.8
Phase 2: Combination Regimen - Cohort 3
9.5
1.2 – 30.4
Phase 2: Combination Regimen - Cohort 4
23.1
5.0 – 53.8
Number of Participants Experiencing Treatment-Emergent Adverse EventsSecondary· Day 1 to 28 days after last dose of study treatment (up to a maximum of 125 weeks in phase 1 and a maximum of 92 weeks in phase 2)
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
5
Phase 1: Dose Escalation - 70 mg
4
Phase 1: Dose Escalation - 90 mg
10
Phase 2: Combination Regimen - Cohort 1
18
Phase 2: Combination Regimen - Cohort 2
3
Phase 2: Combination Regimen - Cohort 3
23
Phase 2: Combination Regimen - Cohort 4
18
Duration of Response (DR)Secondary· Up to approximately 10 months
DR was defined as the time in days from date of the first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the first documentation of objective Progressive Disease (PD) or to death due to any cause in the absence of documented PD. DR was only calculated for the subgroup of participants who achieved a Best Overall Response of CR or PR and was presented for responses assessed by Investigator's assessment.
Data is displayed for Phase 2 only, as no participants experienced an objective response (CR or PR) during Phase 1.
Group
Value
95% CI
Phase 2: Combination Regimen - Cohort 1
115
NA – NA
Phase 2: Combination Regimen - Cohort 3
329
NA – NA
Phase 2: Combination Regimen - Cohort 4
NA
230 – NA
Clinical Benefit Rate (CBR)Secondary· Up to approximately 10 months
Clinical benefit rate (CBR) was defined as the number of participants documented to have a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who were not be able to be assessed for response were counted as non-responders.
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
1
Phase 1: Dose Escalation - 70 mg
2
Phase 1: Dose Escalation - 90 mg
2
Phase 2: Combination Regimen - Cohort 1
4
Phase 2: Combination Regimen - Cohort 2
0
Phase 2: Combination Regimen - Cohort 3
3
Phase 2: Combination Regimen - Cohort 4
5
Progression-Free Survival (PFS)Secondary· Randomization until progressive disease or death due to any cause (up to 42 months)
Progression-free survival (PFS) was defined as the time from date of first study treatment to first Progressive Disease (PD) or death due to any cause in the absence of documented PD per RECIST v1.1
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
3
1.88 – NA
Phase 1: Dose Escalation - 70 mg
NA
NA – NA
Phase 1: Dose Escalation - 90 mg
2
1.51 – 27.57
Phase 2: Combination Regimen - Cohort 1
3
2.01 – 5.86
Phase 2: Combination Regimen - Cohort 2
4
NA – NA
Phase 2: Combination Regimen - Cohort 3
2
1.94 – 14.57
Phase 2: Combination Regimen - Cohort 4
3
2.04 – 9.57
1-Year Survival RateSecondary· 1 year
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
0.40
0.05 – 0.75
Phase 1: Dose Escalation - 70 mg
0.38
0.01 – 0.81
Phase 1: Dose Escalation - 90 mg
0.53
0.18 – 0.80
Phase 2: Combination Regimen - Cohort 1
0.72
0.41 – 0.89
Phase 2: Combination Regimen - Cohort 2
1.00
1.00 – 1.00
Phase 2: Combination Regimen - Cohort 3
0.52
0.31 – 0.70
Phase 2: Combination Regimen - Cohort 4
0.50
0.23 – 0.72
Overall Survival (OS)Secondary· From date of first study treatment until death due to any cause (up to 42 months)
OS was defined as the time from first dose of study treatment to the date of death due to any cause.
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
7
2.40 – 32.99
Phase 1: Dose Escalation - 70 mg
11
7.17 – NA
Phase 1: Dose Escalation - 90 mg
16
3.49 – 26.05
Phase 2: Combination Regimen - Cohort 1
NA
7.37 – NA
Phase 2: Combination Regimen - Cohort 2
NA
NA – NA
Phase 2: Combination Regimen - Cohort 3
15
7.73 – NA
Phase 2: Combination Regimen - Cohort 4
14
5.07 – 20.86
Concentration of Mocetinistat in Blood PlasmaSecondary· Cycle 1 Day 1 pre-dose, 1, 3, and 7 hours post-dose, Cycle 1 Day 15 pre-dose and 1 hour post-dose, Cycle 2 Day 1 pre-dose and 1 hour post-dose, Cycle 3 Day 1 pre-dose and 1 hour post-dose and Cycle 7 Day 1 pre-dose (each cycle is 28 days)
Cycle 1: Day 1 - pre-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
NA
± NA
Phase 1: Mocetinostat 70 mg
0.91
± 83.20
Phase 1: Mocetinostat 90 mg
1.02
± 114.68
Phase 2: Mocetinostat 70 mg
39.65
± 175.97
Cycle 1: Day 1 - 1 hour post-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
19.85
± 441.16
Phase 1: Mocetinostat 70 mg
106.61
± 43.77
Phase 1: Mocetinostat 90 mg
92.56
± 143.96
Phase 2: Mocetinostat 70 mg
12.19
± 289.89
Cycle 1: Day 1 - 3 hours post-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
33.53
± 111.21
Phase 1: Mocetinostat 70 mg
61.63
± 24.78
Phase 1: Mocetinostat 90 mg
55.27
± 53.19
Cycle 1: Day 1 - 7 hours post-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
15.75
± 58.30
Phase 1: Mocetinostat 70 mg
20.92
± 27.20
Phase 1: Mocetinostat 90 mg
33.89
± 45.21
Cycle 1: Day 15 - pre-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
5.36
± NA
Phase 1: Mocetinostat 70 mg
0.98
± 95.06
Phase 1: Mocetinostat 90 mg
3.84
± 202.26
Phase 2: Mocetinostat 70 mg
1.92
± 127.96
Cycle 1: Day 15 - 1 hour post-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
102.67
± 7.17
Phase 1: Mocetinostat 70 mg
22.30
± 14646.88
Phase 1: Mocetinostat 90 mg
18.32
± 1297.79
Phase 2: Mocetinostat 70 mg
10.86
± 330.59
Cycle 2: Day 1 - pre-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
0.72
± NA
Phase 1: Mocetinostat 70 mg
0.85
± NA
Phase 1: Mocetinostat 90 mg
1.22
± 83.65
Phase 1: Mocetinostat 40 mg
NA
± NA
Phase 2: Mocetinostat 70 mg
1.16
± 91.63
Phase 2: Mocetinostat 50 mg
0.68
± NA
Cycle 2: Day 1 - 1 hour post-dose
Group
Value
95% CI
Phase 1: Mocetinostat 50 mg
75.11
± 25.53
Phase 1: Mocetinostat 70 mg
49.30
± 86.19
Phase 1: Mocetinostat 90 mg
2.45
± 83.60
Phase 1: Mocetinostat 40 mg
0.72
± NA
Phase 2: Mocetinostat 70 mg
14.65
± 396.22
Phase 2: Mocetinostat 50 mg
105.00
± NA
Concentration of Durvalumab in Blood PlasmaSecondary· Cycle 1 Day 1 pre-dose + end of infusion, Cycle 1 Day 15 pre-mocetinostat dose, Cycle 2 Day 1 pre-dose, Cycle 3 Day 1 pre-dose, Cycle 4 Day 1 pre-dose + end of infusion, Cycle 7 Day 1 pre-dose + 90 days after participant's last dose (Up to max 133 weeks)
Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group.
Cycle 1: Day 1 - pre-dose
Group
Value
95% CI
Durvalumab
259.18
± 334.86
Cycle 1: Day 1 - end of infusion
Group
Value
95% CI
Durvalumab
385779.56
± 36.49
Cycle 1: Day 15 - pre-Mocetinostat
Group
Value
95% CI
Durvalumab
102925.55
± 40.05
Cycle 2: Day 1 - pre-dose
Group
Value
95% CI
Durvalumab
44140.86
± 130.83
Cycle 3: Day 1 - pre-dose
Group
Value
95% CI
Durvalumab
72049.14
± 91.22
Cycle 4: Day 1 - pre-dose
Group
Value
95% CI
Durvalumab
101852.34
± 89.01
Cycle 4: Day 1 - end of infusion
Group
Value
95% CI
Durvalumab
365307.01
± 81.59
Cycle 7: Day 1 - pre-dose
Group
Value
95% CI
Durvalumab
130335.14
± 70.34
Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the BloodSecondary· Up to approximately 10 months
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
0
Phase 1: Dose Escalation - 70 mg
0
Phase 1: Dose Escalation - 90 mg
1
Phase 2: Combination Regimen - Cohort 1
1
Phase 2: Combination Regimen - Cohort 2
1
Phase 2: Combination Regimen - Cohort 3
1
Phase 2: Combination Regimen - Cohort 4
0
Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at BaselineSecondary· Baseline
No/Low PD-L1 Expression
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
0
Phase 1: Dose Escalation - 70 mg
0
Phase 1: Dose Escalation - 90 mg
0
Phase 2: Combination Regimen - Cohort 1
17
Phase 2: Combination Regimen - Cohort 2
0
Phase 2: Combination Regimen - Cohort 3
6
Phase 2: Combination Regimen - Cohort 4
9
High PD-L1 Expression
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
0
Phase 1: Dose Escalation - 70 mg
0
Phase 1: Dose Escalation - 90 mg
1
Phase 2: Combination Regimen - Cohort 1
0
Phase 2: Combination Regimen - Cohort 2
3
Phase 2: Combination Regimen - Cohort 3
8
Phase 2: Combination Regimen - Cohort 4
1
Missing
Group
Value
95% CI
Phase 1: Dose Escalation - 50 mg
5
Phase 1: Dose Escalation - 70 mg
4
Phase 1: Dose Escalation - 90 mg
8
Phase 2: Combination Regimen - Cohort 1
1
Phase 2: Combination Regimen - Cohort 2
0
Phase 2: Combination Regimen - Cohort 3
9
Phase 2: Combination Regimen - Cohort 4
4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1: Dose Escalation - 50 mg
Serious: 4/5 (80%)
Deaths: 5/5
Phase 1: Dose Escalation - 70 mg
Serious: 1/4 (25%)
Deaths: 2/4
Phase 1: Dose Escalation - 90 mg
Serious: 4/11 (36%)
Deaths: 9/11
Phase 2: Combination Regimen - Cohort 1
Serious: 6/18 (33%)
Deaths: 5/18
Phase 2: Combination Regimen - Cohort 2
Serious: 2/3 (67%)
Deaths: 0/3
Phase 2: Combination Regimen - Cohort 3
Serious: 5/23 (22%)
Deaths: 14/23
Phase 2: Combination Regimen - Cohort 4
Serious: 11/19 (58%)
Deaths: 12/19
Serious adverse events (40 terms)
Reaction
System
Phase 1: Dose Escalation -…
Phase 1: Dose Escalation -…
Phase 1: Dose Escalation -…
Phase 2: Combination Regim…
Phase 2: Combination Regim…
Phase 2: Combination Regim…
Phase 2: Combination Regim…
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
Pericardial effusion
Cardiac disorders
—
—
—
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
—
—
—
Septic shock
Infections and infestations
—
—
—
—
—
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
—
Pericarditis
Cardiac disorders
—
—
—
—
—
—
—
Cardiac tamponade
Cardiac disorders
—
—
—
—
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
Oesophagitis
Gastrointestinal disorders
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
Axillary pain
General disorders
—
—
—
—
—
—
—
Mucosal inflammation
General disorders
—
—
—
—
—
—
—
Non-cardiac chest pain
General disorders
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
—
—
—
Bacterial infection
Infections and infestations
—
—
—
—
—
—
—
Clostridium difficile colitis
Infections and infestations
—
—
—
—
—
—
—
Gastroenteritis adenovirus
Infections and infestations
—
—
—
—
—
—
—
Herpes zoster
Infections and infestations
—
—
—
—
—
—
—
Pyelonephritis
Infections and infestations
—
—
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
—
—
Contusion
Injury, poisoning and procedural complications
—
—
—
—
—
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
—
—
—
—
—
Ejection fraction decreased
Investigations
—
—
—
—
—
—
—
Other adverse events (231 terms — click to expand)
Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.
This study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07393529 — A Pilot Randomized Controlled Trial of a Social Network Intervention
· NA
· recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss
· Phase 1
· recruiting
NCT07246954 — A Chaplain-clinician Led Spiritual Care (PEACE) Intervention on Spiritual/Religious Beliefs Related to Medical Care in P
· NA
· recruiting
NCT06346197 — Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
· Phase 3
· recruiting
NCT07147023 — Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication
· NA
· active not recruiting
Other Mirati Therapeutics Inc. trials
Trials by the same sponsor.
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· Phase 1
· terminated
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 Mirati Therapeutics Inc.
Last refreshed: 6 April 2021
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/NCT02805660.