DCC-3084 monotherapy in patients with solid tumors

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

completed 13 Feb 2026

Decision date (initial)

2025-06-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Deciphera Pharmaceuticals, LLC

External identifiers

EU CT number

2024-517829-12-00

ClinicalTrials.gov

NCT06287463

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacodynamic, Dose response, Pharmacokinetic

Dose Escalation Phase (Part 1):
• To evaluate the safety and tolerability of DCC-3084 as monotherapy.
• To determine the DCC-3084 starting dose for other modules and the recommended dose(s) for expansion in Module A, and if needed or reached, the MTD as monotherapy.
Dose Expansion Phase (Part 2; Expansion EA1):
• To evaluate the anticancer efficacy of DCC-3084 given as monotherapy as determined by evaluation of radiographic response rates according to RECIST v1.1 in NSCLC, melanoma, PDAC, and evaluation of PSA response rates according to PCWG3 in CRPC.

Secondary objectives 5

1. 1. Part 1: To evaluate the antitumor activity of DCC-3084 following treatment as monotherapy according to indication appropriate consensus criteria, for prostate cancer PCWG3 and for all other cancers RECIST v1.1.
2. 2. Part 1: To characterize the PK of DCC-3084 and relevant metabolites (as applicable).
3. 3. Part 2: To further characterize the efficacy of DCC-3084 as monotherapy.
4. 4. Part 2: To further characterize the PK of DCC-3084 and its metabolites (as applicable).
5. 5. Part 2: To further evaluate the safety and tolerability of DCC-3084 as monotherapy.

Conditions and MedDRA coding

Solid tumors driven by the MAPK Pathway

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Part 1 and 2: Able to take oral medication
2. 2. Part 1 and 2: If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements
3. 3. Part 1 and 2: Adequate organ function and electrolytes
4. 4. Part 1 and 2: Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1 at Screening
5. 5. Part 1 and 2: Has a life expectancy of more than 6 months
6. 6. Part 1: Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten rat sarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murine sarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation
7. 7. Part 1: Have exhausted all available standard of care therapies that are known to provide benefit for the participant's condition, as judged by the Investigator
8. 8. Part 2: Documented BRAF gene mutation
9. 9. Part 2: Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting

Exclusion criteria 12

1. 1. Part 1 and 2: Prior treatment with certain BRAF dimer inhibitors
2. 2. Part 1 and 2: Female participant is pregnant or lactating
3. 3. Part 1 and 2: Received any prior or concurrent medications or therapies known to be prohibited with DCC-3084 within 14 days
4. 4. Part 1 and 2: Received any prior antitumor therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-3084
5. 5. Part 1 and 2: Known allergy or hypersensitivity to any component of the study drug
6. 6. Part 1 and 2: Invasive malignancy within 2 years prior to the first dose of study drug other than the study indication or specific types of cancer treated with curative intent
7. 7. Part 1 and 2: Have not recovered from all clinically relevant toxicities from prior therapy
8. 8. Part 1 and 2: Impaired cardiac function
9. 9. Part 1 and 2: History of recent thrombotic or embolic events
10. 10. Part 1 and 2: Malabsorption syndrome or other illness that could affect oral absorption
11. 11. Part 1 and 2: Major surgery within 28 days of the first dose of study drug
12. 12. Part 2: Has known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, Phosphoinositide-3-kinase, catalytic, alpha polypeptide (PI3KCA), or Phosphatase and TENsin homolog deleted on chromosome 10 (PTEN)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1: Number of Participants with Dose-limiting Toxicities (DLTs)
2. Part 2: Objective Response Rate (ORR); ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.

Secondary endpoints 4

1. 1. Part 1: ORR (the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol)
2. 2. Part 1 and 2: Progression-Free Survival (PFS). PFS is the time from start of therapy to PD or death due to any cause.
3. 3. Part 1 and 2: Overall Survival (OS). OS is the time from start of therapy to death from any cause.
4. 4. Part 1 and 2: Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)

Investigational products

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

Test 2

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 21

Locations

3 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Results and documents

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

Documents 17 files

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

Application history

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