DT2216 + Irinotecan for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for young people with solid tumors or fibrolamellar cancer that hasn't improved with standard treatments. Researchers are testing DT2216, an experimental treatment that blocks a protein aiding cancer cell survival, alongside irinotecan, a medication that prevents cancer cells from dividing. The trial aims to assess the treatment's safety, effectiveness, and optimal dosage. It seeks participants with solid tumors or fibrolamellar cancer that has recurred or not responded to previous treatments, and who have recovered from past cancer therapies. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking other anti-cancer medications and certain other drugs before enrolling. You must also stop taking drugs that strongly affect the liver enzyme CYP3A4 at least 14 days before joining the study. If you are on corticosteroids, you need to be on a stable or decreasing dose for at least 7 days before enrolling.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that DT2216 is safe and easy to tolerate. Studies have found that it does not cause thrombocytopenia, a condition where blood has fewer platelets than normal. This is important because DT2216 might lead to fewer bleeding-related side effects compared to similar treatments.
Irinotecan, a well-known cancer drug, works by stopping an enzyme cancer cells need to grow. While irinotecan can have side effects, it is generally safe under a doctor's care.
Combining DT2216 with irinotecan may be effective against cancer, and so far, this combination appears well-tolerated. Earlier tests showed that patients managed the treatment without major problems. However, as the trial continues, more information will help confirm its safety and effectiveness for children, adolescents, and young adults with relapsed or hard-to-treat cancers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about DT2216 combined with Irinotecan because this combination offers a new approach for treating cancer. Unlike traditional therapies that might target cancer cells broadly, DT2216 specifically targets a protein called BCL-XL, which plays a role in cancer cell survival. This specificity could mean fewer side effects compared to standard chemotherapy. Also, the combination with Irinotecan, a well-known chemotherapy drug, might enhance its effectiveness, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for relapsed or refractory solid tumors or fibrolamellar cancer?
Research has shown that DT2216, one of the treatments in this trial, may help treat certain cancers by breaking down a protein called BCL-xL, which cancer cells need to survive. In mouse studies, DT2216 reduced tumor size without causing major side effects. Irinotecan, the other treatment in this trial, already treats various cancers by disrupting the DNA repair process in cancer cells, leading to their death. Studies have found that irinotecan can extend life by about 9.9 months when used after other treatments have failed. When combined in this trial, DT2216 and irinotecan might more effectively stop cancer cells from growing and surviving.678910
Who Is on the Research Team?
Michael V Ortiz
Principal Investigator
Pediatric Early Phase Clinical Trial Network
Are You a Good Fit for This Trial?
This trial is for children, adolescents, and young adults with solid tumors or fibrolamellar cancer that has relapsed or is refractory. Ages eligible vary: 1-21 years for Phase I and 1-39 years for Phase II. Participants need measurable disease (Phase II) or evaluable disease (Phase I), except primary central nervous system tumors. They must have an acceptable performance status based on ECOG scores.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DT2216 and irinotecan intravenously in cycles, with DT2216 administered on days 1, 4, 8, 11, 15, and 18, and irinotecan on days 2-6 of cycle 1, and on days 1-5 of remaining cycles. Cycles repeat every 21 days for up to 35 cycles (24 months).
Follow-up
Participants are monitored for safety and effectiveness after treatment completion at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.
What Are the Treatments Tested in This Trial?
Interventions
- DT2216
- Irinotecan
Trial Overview
The trial tests the safety and effectiveness of DT2216 combined with irinotecan in treating relapsed/refractory solid tumors and fibrolamellar carcinoma. DT2216 targets a protein essential for tumor cell survival, while irinotecan inhibits enzymes needed for DNA repair in cells.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive DT2216 IV over 30 minutes on days 1, 4, 8, 11, 15, and 18 of each cycle and irinotecan IV over 90 minutes on days 2-6 of cycle 1, and on days 1-5 of remaining cycles. Cycles repeat every 21 days for up to 35 cycles (24 months) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
Citations
1.
ashpublications.org
ashpublications.org/blood/article/146/3/341/536433/Efficacy-of-a-novel-BCL-xL-degrader-DT2216-inEfficacy of a novel BCL-xL degrader, DT2216, in preclinical ...
The promising efficacy of DT2216 in post-MPN AML was evidenced by reduced cell viability; on-target degradation of BCL-xL; synergistic ...
Efficacy of a novel BCL-xL degrader, DT2216, in ... - PubMed
In summary, our data indicate that the survival of post-MPN AML is BCL-xL dependent, and DT2216 may offer therapeutic advantage in this high ...
3.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_2/CT063/761488/Abstract-CT063-First-in-human-phase-1-study-ofFirst in human phase 1 study of DT2216, a selective BCL-xL ...
Median overall survival was 7.9 months (95% CI 4.0 - NE). Plasma AUC of DT2216 was dose proportional, and all PK parameters were independent of ...
DT2216—a Bcl-xL-specific degrader is highly active against ...
In vivo, DT2216 alone was highly effective against MyLa TCL xenografts in mice without causing significant thrombocytopenia or other toxicity.
DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer
DT2216 is a drug that degrades a protein called BCL-XL which helps to protect cancer cells from cell death. Paclitaxel is an anti-cancer drug that is already ...
NCT06620302 | Testing the Addition of an Anti-cancer ...
Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or ...
Phase I results on the efficacy, safety and ...
In vivo, the combination of lurbinectedin and irinotecan showed a synergistic antitumor effect in athymic mice bearing colon, non-small cell lung cancer (NSCLC) ...
New Clinical Trial: Assisted Suicide of FLC Cancer Cells
This trial established DT2216's safety and tolerability, and it confirmed that the drug does not cause thrombocytopenia. Pre-clinical testing of ...
A Phase 1/2 Study Assessing the Addition of DT2216 to ...
DT2216 may help to kill cancer cells by blocking Bcl-xL, a protein that some cancers need to survive. Irinotecan is an anti-cancer drug that is part of the ...
Targeting BCL-XL in fibrolamellar hepatocellular carcinoma
DT2216, by itself and in combination with irinotecan, was associated with less thrombocytopenia than standard doses of navitoclax alone, thus establishing its ...
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