DCC-3116 + Anticancer Therapies for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Deciphera Pharmaceuticals LLC

Must not be taking: CYP3A4 inhibitors, P-gp inducers

Disqualifiers: Heart disease, CNS metastases, HIV, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of DCC-3116 in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of DCC-3116 with other anticancer agents.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including those that strongly affect liver enzymes (CYP3A4) or P-glycoprotein, at least 14 days before starting the study drug. You also need to avoid grapefruit and grapefruit juice for 14 days before the trial.

What safety data exists for DCC-3116 and related anticancer therapies?

Anticancer drugs, including those similar to DCC-3116, can cause serious side effects, but these are often not preventable. Some adverse reactions, like liver issues or bleeding, may be preventable with proper dosage and monitoring. Antibody-drug conjugates, another type of anticancer therapy, are generally well tolerated but can cause side effects like nausea, hair loss, and heart issues, which require careful monitoring. ^{1 2 3 4 5}

What makes the drug DCC-3116 unique for treating advanced cancers?

DCC-3116 is unique because it is being studied in combination with other anticancer therapies for advanced cancers, potentially offering a novel approach to treatment. While specific details about DCC-3116's mechanism or administration are not provided, its combination with existing therapies suggests it may enhance or complement their effects. ^{6 7 8 9 10}

Research Team

Clinical Team

Principal Investigator

Deciphera Pharmaceuticals, LLC

Eligibility Criteria

Adults with advanced colorectal cancer (CRC) having a specific mutation (BRAF V600E), or gastrointestinal stromal tumor (GIST) with certain mutations, who have tried some treatments but not others specified in the study criteria. Participants must be able to provide biopsy samples and have a life expectancy over 3 months.

Inclusion Criteria

My cancer can be measured by tests.

My colorectal cancer has a BRAF V600E mutation.

Must agree to provide an on treatment biopsy

Exclusion Criteria

Must not have received investigational therapies with unknown safety and PK profile within specified time periods prior to the first dose of study drug

I haven't taken strong or moderate drugs affecting CYP3A4 or P-gp, including St. John's wort, recently.

I haven't had grapefruit or its juice in the last 14 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

DCC-3116 tablets in escalating dose cohorts in 28-day cycles will be administered in combination with ripretinib once daily (QD)

28-day cycles

Expansion

DCC-3116 tablets will be administered in combination with ripretinib in 28-day cycles to evaluate preliminary efficacy in participants with 2nd-line advanced gastrointestinal stromal tumor (GIST)

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• DCC-3116 (Other)
• Encorafenib (Other)
• Ripretinib (Other)

Trial Overview The trial is testing DCC-3116 in combination with other anticancer drugs like Ripretinib, Cetuximab, and Encorafenib. It's an early-stage trial to see how well these combinations work together for treating CRC and GIST.

Participant Groups

Group I: Expansion (Part 2, Module B) Experimental Treatment 2 Interventions

DCC-3116 tablets will be administered in combination with ripretinib in 28-day cycles to evaluate preliminary efficacy in participants with 2nd-line advanced gastrointestinal stromal tumor (GIST).

Group II: Expansion (Part 2, Module A) Experimental Treatment 1 Intervention

Expansion Module A Part 2 DCC-3116 combination closed on January 8, 2024, with no participants enrolled.

Group III: Dose Escalation (Part 1, Module B) Experimental Treatment 2 Interventions

DCC-3116 tablets in escalating dose cohorts in 28-day cycles will be administered in combination with ripretinib once daily (QD).

Group IV: Dose Escalation (Part 1, Module A) Experimental Treatment 1 Intervention

Escalation Module A Part 1 DCC-3116 combination closed on January 8, 2024, with no participants enrolled.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Southern California - Norris Comprehensive Cancer Center Los Angeles, CA

Washington University School of Medicine - Siteman Cancer Center Saint Louis, MO

UCLA Department of Medicine-Hematology/Oncology Los Angeles, CA

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

Deciphera Pharmaceuticals LLC

Lead Sponsor

Trials

17

Patients Recruited

1,900+

Deciphera Pharmaceuticals, LLC

Lead Sponsor

Trials

19

Patients Recruited

2,100+

Pfizer

Industry Sponsor

Trials

4712

Patients Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and benefits of anticancer drugs in advanced cancer patients: A systematic review and meta-analysis. Moreau Bachelard, C., Coquan, E., du Rusquec, P., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity profile of antibody-drug conjugates in breast cancer: practical considerations. D'Arienzo, A., Verrazzo, A., Pagliuca, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventable and potentially preventable serious adverse reactions induced by oral protein kinase inhibitors through a database of adverse drug reaction reports. Egron, A., Olivier-Abbal, P., Gouraud, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence- and consensus-based guidelines for drug-drug interactions with anticancer drugs; A practical and universal tool for management. van Leeuwen, RWF., le Comte, M., Reyners, AKL., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolving therapeutic landscape of trastuzumab-drug conjugates: Future perspectives beyond HER2-positive breast cancer. von Arx, C., De Placido, P., Caltavituro, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of deleted in colorectal carcinoma gene on proliferation of ovarian cancer cell line SKOV-3 in vivo and in vitro. Cai, Y., Hu, CJ., Wang, J., et al.[2019]

Dicycloplatin (DCP) demonstrated a favorable safety profile in a Phase I study with 29 cancer patients, tolerating doses up to 550 mg/m², while showing potential efficacy with two partial responses in patients previously treated with other platinum-based chemotherapies.

DCP is stable in aqueous solution, which enhances its bioavailability and pharmacokinetics compared to carboplatin, making it a promising candidate for further clinical evaluation, with a recommended starting dose of 450 mg/m² for Phase II studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of the novel platin complex dicycloplatin: clinical and pharmacokinetic results. Li, S., Huang, H., Liao, H., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dichloroacetate reverses the hypoxic adaptation to bevacizumab and enhances its antitumor effects in mouse xenografts. Kumar, K., Wigfield, S., Gee, HE., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I open-labeled, single-arm, dose-escalation, study of dichloroacetate (DCA) in patients with advanced solid tumors. Chu, QS., Sangha, R., Spratlin, J., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dichloroacetate (DCA) and Cancer: An Overview towards Clinical Applications. Tataranni, T., Piccoli, C.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Risks and benefits of anticancer drugs in advanced cancer patients: A systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Toxicity profile of antibody-drug conjugates in breast cancer: practical considerations. [2023]

3. France pubmed.ncbi.nlm.nih.gov

Preventable and potentially preventable serious adverse reactions induced by oral protein kinase inhibitors through a database of adverse drug reaction reports. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Evidence- and consensus-based guidelines for drug-drug interactions with anticancer drugs; A practical and universal tool for management. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The evolving therapeutic landscape of trastuzumab-drug conjugates: Future perspectives beyond HER2-positive breast cancer. [2023]

6. China pubmed.ncbi.nlm.nih.gov

Influence of deleted in colorectal carcinoma gene on proliferation of ovarian cancer cell line SKOV-3 in vivo and in vitro. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of the novel platin complex dicycloplatin: clinical and pharmacokinetic results. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

Dichloroacetate reverses the hypoxic adaptation to bevacizumab and enhances its antitumor effects in mouse xenografts. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A phase I open-labeled, single-arm, dose-escalation, study of dichloroacetate (DCA) in patients with advanced solid tumors. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Dichloroacetate (DCA) and Cancer: An Overview towards Clinical Applications. [2020]