Clinical Trials List
Protocol NumberDCC-3116-01-001
Completed
2025-09-01 - 2028-09-01
Phase I
Recruiting4
ICD-10C69.40
Malignant neoplasm of unspecified ciliary body
ICD-10C69.41
Malignant neoplasm of right ciliary body
ICD-10C69.42
Malignant neoplasm of left ciliary body
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9190.0
Malignant neoplasm of eyeball, except conjunctiva, cornea, retina and choroid
A Phase 1/2, First in Human Study of DCC-3116 as Monotherapy and in Combination with RAS/MAPK Pathway Inhibitors in Patients with Advanced or Metastatic Solid Tumors with RAS/MAPK Pathway Mutations
-
Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
Deciphera Pharmaceuticals, LLC
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ming-Mo Hou 無
- Jen-Shi Chen 無
- Chan-Keng Yang 無
- 徐執中 無
- 陳建銘 無
- Po-Jung Su 無
- 余紹銘 無
- Hung-Chih Hsu 無
- 黃文冠 無
- Wen-Chi Shen 無
- 張境夫 無
- Tsai-Sheng Yang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 徐偉勛 無
- Jih-Hsiang Lee 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chao-Hua Chiu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Solid Tumors
Objectives
Dose Escalation Phase (Part 1):
• To evaluate the safety and tolerability of DCC-3116 as monotherapy, in combination with
trametinib, in combination with binimetinib, and in combination with sotorasib
• To determine the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose
(MTD) of DCC-3116 as monotherapy
• To determine the RP2D and/or MTD of DCC-3116 in combination with trametinib
• To determine the RP2D and/or MTD of DCC-3116 in combination with binimetinib
• To determine the RP2D and/or MTD of DCC-3116 in combination with sotorasib
Test Drug
table
Active Ingredient
DCC-3116
Dosage Form
128
Dosage
25 and 100 mg
Endpoints
Dose Escalation Phase (Part 1):
Safety: Safety endpoints that will be evaluated include the following:
• Dose-limiting toxicities (DLTs)
• Treatment-emergent adverse events (TEAEs)
• Serious adverse events (SAEs)
• Dose reduction, interruption, or discontinuation of study drug due to toxicity
Safety: Safety endpoints that will be evaluated include the following:
• Dose-limiting toxicities (DLTs)
• Treatment-emergent adverse events (TEAEs)
• Serious adverse events (SAEs)
• Dose reduction, interruption, or discontinuation of study drug due to toxicity
Inclution Criteria
Participants must meet all of the following criteria to be eligible to enroll in the
study.
1. Male or female participant ≥18 years of age
2. Dose Escalation Phase (Part 1):
a. Pathologically confirmed diagnosis of an advanced or metastatic solid tumor with a
documented RAS, NF1, or RAF mutations. A molecular pathology report documenting
mutational status of RAS, NF1, or RAF must be available
b. Have progressed despite standard therapies, or for whom conventional therapy is not
considered effective or tolerable, as judged by the Investigator. Must have received at
least 1 prior line of anticancer therapy and have a life expectancy of more than 3 months
i. Participants with a documented mutation in BRAF V600E or V600K must
have received approved treatments known to provide clinical benefit prior to
study entry
ii. Participants enrolled in the DCC-3116 and sotorasib cohort (Cohort D) must
have a KRAS G12C mutation and may or may not have received prior
treatment with a G12C inhibitor
3. Dose Expansion Phase (Part 2): Have progressed despite standard therapies listed below, or
for whom conventional therapy is not considered effective or tolerable, as judged by the
Investigator
a. Expansion Cohort 1: Patients with PDAC
i. Must have pathologically confirmed PDAC with a documented mutation in
KRAS. A molecular pathology report documenting mutational status of
KRAS must be available
ii. Received only 1 prior line of systemic therapy in the advanced or metastatic
setting and have a life expectancy of more than 3 months in the judgment of
the Investigator
b. Expansion Cohort 2: Patients with NSCLC
i. Must have pathologically confirmed NSCLC with a documented mutation in
KRAS, NRAS, NF1, or BRAF. A molecular pathology report documenting
mutational status of KRAS, NRAS, NF1, or BRAF must be available
ii. Received at least 2 prior lines but no more than 4 prior lines of systemic
therapy in the advanced or metastatic setting and have a life expectancy of
more than 3 months in the judgment of the Investigator
- Participants with a documented mutation in BRAF V600E or KRAS
G12C must have received approved treatments known to provide clinical
benefit prior to study entry
c. Expansion Cohort 3: Patients with CRC
i. Must have pathologically confirmed CRC with a documented mutation in
KRAS, NRAS, NF1, or BRAF. A molecular pathology report documenting
mutational status of KRAS, NRAS, NF1, or BRAF must be available
ii. Received at least 2 prior lines of systemic therapy in the advanced or
metastatic setting and have a life expectancy of more than 3 months in the
judgment of the Investigator
- Participants with a documented mutation in BRAF V600E or KRAS
G12C must have received targeted treatment if an approved targeted
therapy is available
study.
1. Male or female participant ≥18 years of age
2. Dose Escalation Phase (Part 1):
a. Pathologically confirmed diagnosis of an advanced or metastatic solid tumor with a
documented RAS, NF1, or RAF mutations. A molecular pathology report documenting
mutational status of RAS, NF1, or RAF must be available
b. Have progressed despite standard therapies, or for whom conventional therapy is not
considered effective or tolerable, as judged by the Investigator. Must have received at
least 1 prior line of anticancer therapy and have a life expectancy of more than 3 months
i. Participants with a documented mutation in BRAF V600E or V600K must
have received approved treatments known to provide clinical benefit prior to
study entry
ii. Participants enrolled in the DCC-3116 and sotorasib cohort (Cohort D) must
have a KRAS G12C mutation and may or may not have received prior
treatment with a G12C inhibitor
3. Dose Expansion Phase (Part 2): Have progressed despite standard therapies listed below, or
for whom conventional therapy is not considered effective or tolerable, as judged by the
Investigator
a. Expansion Cohort 1: Patients with PDAC
i. Must have pathologically confirmed PDAC with a documented mutation in
KRAS. A molecular pathology report documenting mutational status of
KRAS must be available
ii. Received only 1 prior line of systemic therapy in the advanced or metastatic
setting and have a life expectancy of more than 3 months in the judgment of
the Investigator
b. Expansion Cohort 2: Patients with NSCLC
i. Must have pathologically confirmed NSCLC with a documented mutation in
KRAS, NRAS, NF1, or BRAF. A molecular pathology report documenting
mutational status of KRAS, NRAS, NF1, or BRAF must be available
ii. Received at least 2 prior lines but no more than 4 prior lines of systemic
therapy in the advanced or metastatic setting and have a life expectancy of
more than 3 months in the judgment of the Investigator
- Participants with a documented mutation in BRAF V600E or KRAS
G12C must have received approved treatments known to provide clinical
benefit prior to study entry
c. Expansion Cohort 3: Patients with CRC
i. Must have pathologically confirmed CRC with a documented mutation in
KRAS, NRAS, NF1, or BRAF. A molecular pathology report documenting
mutational status of KRAS, NRAS, NF1, or BRAF must be available
ii. Received at least 2 prior lines of systemic therapy in the advanced or
metastatic setting and have a life expectancy of more than 3 months in the
judgment of the Investigator
- Participants with a documented mutation in BRAF V600E or KRAS
G12C must have received targeted treatment if an approved targeted
therapy is available
Exclusion Criteria
Participants meeting any of the following criteria will be excluded from the
study:
1. Must not have received the following within the specified time periods prior to the first dose
of study drug:
a. Prior therapies (anticancer or therapies given for other reasons) that are known strong or
moderate inhibitors or inducers of CYP3A4 or P-gp (refer to Section 9.8.3) including
certain herbal medications (eg, St. John’s Wort): 14 days or 5× the half-life of the
medication (whichever is longer)
b. All other prior anticancer therapies or any therapy that is investigational for the
participant’s condition with a known safety and PK profile: 14 days or 5× the half-life of
the medication (whichever is shorter)
c. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough
data on the investigational therapy to assess the risk for drug-drug interactions and late
toxicities of prior therapy as low, the Sponsor’s Medical Monitor may approve a shorter
washout of 14 days
d. Grapefruit or grapefruit juice: 14 days
2. Have not recovered from all toxicities from prior therapy according to National Cancer
Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 to
Grade ≤1 or participant baseline prior to first dose of study drug (excluding alopecia).
Participant baseline is defined as no change in severity grade within 28 days prior to signed
informed consent
3. Presence or history of central nervous system (CNS) metastases or leptomeningeal disease,
with the following exceptions:
• If there is a history of brain metastases, they must be stable for at least 6 months (no
new metastases and no evidence of progression of known metastases at Screening
compared to historical scans)
• If there is a history of leptomeningeal disease, it must have cleared at least 6 months
prior to Screening
• If there are neurologic symptoms consistent with CNS disease, they must not be new
or increasing in severity over at least 6 months prior to Screening
• If there is a history of CNS metastasis or leptomeningeal disease, it must not require
continued therapy
4. New York Heart Association Class III or IV heart disease, active ischemia, or any other
uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac
arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or
myocardial infarction within 6 months prior to the first dose of study drug
5. Prolongation of the QT interval corrected by Fridericia’s formula (QTcF) based on repeated
demonstration of QTcF >450 ms in males or >470 ms in females at Screening or history of
long QT syndrome
6. Left ventricular ejection fraction (LVEF) <50% at Screening
7. Systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including
ischemic attacks) or moderate hemoptysis within 6 months prior to the first dose of study drug
8. Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events
(eg, pulmonary embolism) within 1 month prior to the start of study drug
Note: Participants with thromboembolic events before the first dose of study drug on
stable anticoagulation therapy or who do not require anticoagulation therapy are eligible.
9. Malabsorption syndrome or other illness that could affect oral absorption as judged by the
Investigator
10. Bone disease that requires ongoing treatment or has required treatment, including radiation,
bisphosphonates, and/or denosumab
11. Major surgery within 4 weeks of the first dose of study drug. All surgical wounds must be
healed and free of infection or dehiscence before the first dose of the study drug
12. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active
infection, or any other condition that in the judgment of the Investigator could compromise
compliance with the protocol, interfere with the interpretation of study results, or predispose
the participant to safety risks
13. Known allergy or hypersensitivity to any component of DCC-3116, trametinib, binimetinib,
sotorasib, or any of their excipients. Please refer to the current version of the IB for a list of
excipients for DCC-3116. Please refer to the package inserts for trametinib, binimetinib, and
sotorasib excipients
14. For participants receiving DCC-3116 and trametinib combination or DCC-3116 and
binimetinib combination: previous treatment with trametinib or binimetinib that resulted in
treatment discontinuation due to intolerability as a result of an adverse event (AE) that was
considered related to trametinib or binimetinib with the following exception: participants who
had to stop prior trametinib due to pyrexia may be considered for treatment in a DCC-3116
with binimetinib cohort
15. For participants receiving DCC-3116 and sotorasib combination in Dose Escalation Part 1:
previous treatment with sotorasib that resulted in treatment discontinuation due to
intolerability as a result of an adverse event (AE) that was considered related to sotorasib
16. For participants receiving DCC-3116 and sotorasib combination: Use of proton pump
inhibitors (PPIs) and H2 receptor antagonists that cannot be discontinued 3 days prior to the
start of study drug administration
17. HIV infection is an exclusion criterion unless all of the following requirements are met:
• CD4 count > 350/μL
• No AIDS-defining opportunistic infection in the last 12 months
• Stable anti-retroviral regimen with medications that are not prohibited by the protocol
(Section 9.8.3) for at least 4 weeks with HIV viral load less than 400 copies/mL prior
to enrollment
18. Hepatitis B virus (HBV) infection is an exclusion criterion unless the HBV DNA viral load is
negative, and the participant is on a stable HBV suppressive regimen with medications that
are not prohibited by the protocol (Section 9.8.3) for at least 4 weeks prior to enrollment
19. Hepatitis C virus (HCV) infection is an exclusion criterion unless the HCV RNA viral load is
negative, and the participant has either completed curative HCV therapy or is on a stable
HCV therapy regimen with medications that are not prohibited by the protocol (Section 9.8.3)
for at least 4 weeks prior to enrollment
20. Female participant is pregnant or lactating
21. Ongoing participation in an interventional study. Ongoing participation in a noninterventional
study (including observational studies) is permitted
22. For participants receiving DCC-3116 and binimetinib combination: Known Gilbert’s
syndrome
study:
1. Must not have received the following within the specified time periods prior to the first dose
of study drug:
a. Prior therapies (anticancer or therapies given for other reasons) that are known strong or
moderate inhibitors or inducers of CYP3A4 or P-gp (refer to Section 9.8.3) including
certain herbal medications (eg, St. John’s Wort): 14 days or 5× the half-life of the
medication (whichever is longer)
b. All other prior anticancer therapies or any therapy that is investigational for the
participant’s condition with a known safety and PK profile: 14 days or 5× the half-life of
the medication (whichever is shorter)
c. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough
data on the investigational therapy to assess the risk for drug-drug interactions and late
toxicities of prior therapy as low, the Sponsor’s Medical Monitor may approve a shorter
washout of 14 days
d. Grapefruit or grapefruit juice: 14 days
2. Have not recovered from all toxicities from prior therapy according to National Cancer
Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 to
Grade ≤1 or participant baseline prior to first dose of study drug (excluding alopecia).
Participant baseline is defined as no change in severity grade within 28 days prior to signed
informed consent
3. Presence or history of central nervous system (CNS) metastases or leptomeningeal disease,
with the following exceptions:
• If there is a history of brain metastases, they must be stable for at least 6 months (no
new metastases and no evidence of progression of known metastases at Screening
compared to historical scans)
• If there is a history of leptomeningeal disease, it must have cleared at least 6 months
prior to Screening
• If there are neurologic symptoms consistent with CNS disease, they must not be new
or increasing in severity over at least 6 months prior to Screening
• If there is a history of CNS metastasis or leptomeningeal disease, it must not require
continued therapy
4. New York Heart Association Class III or IV heart disease, active ischemia, or any other
uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac
arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or
myocardial infarction within 6 months prior to the first dose of study drug
5. Prolongation of the QT interval corrected by Fridericia’s formula (QTcF) based on repeated
demonstration of QTcF >450 ms in males or >470 ms in females at Screening or history of
long QT syndrome
6. Left ventricular ejection fraction (LVEF) <50% at Screening
7. Systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including
ischemic attacks) or moderate hemoptysis within 6 months prior to the first dose of study drug
8. Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events
(eg, pulmonary embolism) within 1 month prior to the start of study drug
Note: Participants with thromboembolic events before the first dose of study drug on
stable anticoagulation therapy or who do not require anticoagulation therapy are eligible.
9. Malabsorption syndrome or other illness that could affect oral absorption as judged by the
Investigator
10. Bone disease that requires ongoing treatment or has required treatment, including radiation,
bisphosphonates, and/or denosumab
11. Major surgery within 4 weeks of the first dose of study drug. All surgical wounds must be
healed and free of infection or dehiscence before the first dose of the study drug
12. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active
infection, or any other condition that in the judgment of the Investigator could compromise
compliance with the protocol, interfere with the interpretation of study results, or predispose
the participant to safety risks
13. Known allergy or hypersensitivity to any component of DCC-3116, trametinib, binimetinib,
sotorasib, or any of their excipients. Please refer to the current version of the IB for a list of
excipients for DCC-3116. Please refer to the package inserts for trametinib, binimetinib, and
sotorasib excipients
14. For participants receiving DCC-3116 and trametinib combination or DCC-3116 and
binimetinib combination: previous treatment with trametinib or binimetinib that resulted in
treatment discontinuation due to intolerability as a result of an adverse event (AE) that was
considered related to trametinib or binimetinib with the following exception: participants who
had to stop prior trametinib due to pyrexia may be considered for treatment in a DCC-3116
with binimetinib cohort
15. For participants receiving DCC-3116 and sotorasib combination in Dose Escalation Part 1:
previous treatment with sotorasib that resulted in treatment discontinuation due to
intolerability as a result of an adverse event (AE) that was considered related to sotorasib
16. For participants receiving DCC-3116 and sotorasib combination: Use of proton pump
inhibitors (PPIs) and H2 receptor antagonists that cannot be discontinued 3 days prior to the
start of study drug administration
17. HIV infection is an exclusion criterion unless all of the following requirements are met:
• CD4 count > 350/μL
• No AIDS-defining opportunistic infection in the last 12 months
• Stable anti-retroviral regimen with medications that are not prohibited by the protocol
(Section 9.8.3) for at least 4 weeks with HIV viral load less than 400 copies/mL prior
to enrollment
18. Hepatitis B virus (HBV) infection is an exclusion criterion unless the HBV DNA viral load is
negative, and the participant is on a stable HBV suppressive regimen with medications that
are not prohibited by the protocol (Section 9.8.3) for at least 4 weeks prior to enrollment
19. Hepatitis C virus (HCV) infection is an exclusion criterion unless the HCV RNA viral load is
negative, and the participant has either completed curative HCV therapy or is on a stable
HCV therapy regimen with medications that are not prohibited by the protocol (Section 9.8.3)
for at least 4 weeks prior to enrollment
20. Female participant is pregnant or lactating
21. Ongoing participation in an interventional study. Ongoing participation in a noninterventional
study (including observational studies) is permitted
22. For participants receiving DCC-3116 and binimetinib combination: Known Gilbert’s
syndrome
The Estimated Number of Participants
-
Taiwan
10 participants
-
Global
88 participants
