A Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Deciphera Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Mar 2026 → ongoing

Decision date (initial)

2025-04-14

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Deciphera Pharmaceuticals, LLC

External identifiers

EU CT number

2024-516476-15-00

ClinicalTrials.gov

NCT05957367

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic, Dose response

Part 2 (Expansion):
• To evaluate the objective response rate of combination therapy at recommended
dose(s) in each expansion cohort using histology-specific consensus response criteria.

Secondary objectives 3

1. To further characterize the efficacy of DCC-3116 at recommended dose(s) in combination with module-specific anticancer therapies
2. To evaluate the safety and tolerability of DCC-3116 in combination with module-specific anticancer therapies
3. To characterize the PK of DCC-3116 and module-specific anticancer therapies in expansion cohorts

Conditions and MedDRA coding

Advanced gastrointestinal stromal tumor (GIST)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male or female ≥18 years of age
2. Pathologically confirmed GIST with documented mutation in KIT exon 11.
3. Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST.
4. Measurable disease.
5. Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1.
6. Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening.
7. Must provide a fresh tumor biopsy.

Exclusion criteria 8

1. Must not have received the following within the specified time periods prior to the first dose of study drug: 1.Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer). 2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter). 3.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. 4.Grapefruit or grapefruit juice: 14 days.
2. Have not recovered from all clinically relevant toxicities from prior therapy.
3. New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, 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.
4. Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease.
5. Malabsorption syndrome.
6. Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug.
7. Major surgery within 4 weeks of the first dose of study drug.
8. Active HIV, Hepatitis B or Hepatitis C infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Efficacy: ORR based on Investigator assessment, which is defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per the mRECIST

Secondary endpoints 3

1. Efficacy: DOR, DCR at 16, 24, and 32 weeks, Time to response, PFS, OS.
2. Safety: TEAEs, SAEs, TEAEs leading to dose reduction, interruption, or discontinuation of any/all study drug(s).
3. Pharmacokinetics: PK endpoints will be evaluated for DCC-3116, ripretinib, and DP-5439. These PK parameters, if determinable, may include tmax, Cmax, Cmin, AUC.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Deciphera Pharmaceuticals Inc.

Sponsor organisation

Deciphera Pharmaceuticals Inc.

Address

200 Smith Street

City

Waltham

Postcode

02451-0099

Country

United States

Scientific contact point

Organisation

Deciphera Pharmaceuticals Inc.

Contact name

Clinical trial information

Public contact point

Organisation

Deciphera Pharmaceuticals Inc.

Contact name

Clinical trial information

Third parties 17

Locations

8 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 122 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications