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DT2216 with Chemotherapy for Relapsed/Refractory Solid Tumors and Fibrolamellar Carcinoma

This study is testing a new anti-cancer drug, DT2216, along with the usual chemotherapy drug, Irinotecan. It's for children, adolescents, and young adults (ages 1 to 39) who have solid tumors or fibrolamellar carcinoma that has returned or hasn't responded to previous treatments. Researchers want to find the safest and most effective dose of DT2216 when given with Irinotecan. DT2216 works by blocking a protein called Bcl-xL, which helps cancer cells survive. Irinotecan is a chemotherapy drug that stops cancer cells from dividing and repairing themselves. The study will also look at how well this combination treatment works against these cancers. The study is currently unclear on its recruitment status and plans to enroll 81 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase 1/2 study, which means it will first look at safety and dosing, then at how well the treatment works.
What's involved
Participants will receive DT2216 and Irinotecan intravenously (through a vein). They will also have blood samples collected.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for up to 30 days after their last dose of study drug. Dose-limiting toxicity will be measured for up to 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06620302

Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma

Suspended
PHASE1Ages 1–39InterventionalTreatment
Children's Oncology Group
~81 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Bcl-XL Proteolysis Targeting Chimera DT2216Biospecimen CollectionIrinotecan

At a glance

Recruiting sites
0 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 30 days after last dose of study drug
+9 more outcomes measured

Conditions

Childhood Fibrolamellar Carcinoma
Recurrent Childhood Fibrolamellar Carcinoma
Recurrent Childhood Malignant Solid Neoplasm
Recurrent Fibrolamellar Carcinoma
Recurrent Malignant Solid Neoplasm
Refractory Childhood Fibrolamellar Carcinoma
Refractory Childhood Malignant Solid Neoplasm
Refractory Fibrolamellar Carcinoma
Refractory Malignant Solid Neoplasm

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Fibrolamellar CarcinomaSolid NeoplasmDNAJB1:PRKACA

NCT06620302

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texasno site contact published

  • C S Mott Children's Hospital

    Ann Arbor, Michiganno site contact published

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgiano site contact published

  • Children's Hospital Colorado

    Aurora, Coloradono site contact published

  • Children's Hospital Los Angeles

    Los Angeles, Californiano site contact published

  • Children's Hospital of Alabama

    Birmingham, Alabamano site contact published

  • Children's Hospital of Orange County

    Orange, Californiano site contact published

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael V Ortiz · PRINCIPAL_INVESTIGATOR · Pediatric Early Phase Clinical Trial Network

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

PHASE 1: Patients between ≥ 1 year and ≤ 21 years of age at the time of study enrollment
PHASE 2: Patients between ≥ 1 year and ≤ 39 years of age at the time of study enrollment
PHASE 1: Patients with recurrent/refractory solid tumors excluding primary central nervous system tumors
PHASE 2: Patients with (FLC), which must include genomic confirmation of the DNAJB1:PRKACA fusion performed at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
PHASE 1: Patients must have either measurable or evaluable disease
PHASE 2: Patients must have measurable disease
PHASE 1: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
PHASE 2: Patients must have FLC which is recurrent/refractory to at least one line of prior systemic therapy
Patients with FLC that is unresectable at initial diagnosis but is not recurrent/refractory to at least one prior line of systemic therapy nor metastatic are NOT eligible for either phase 1 or phase 2
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age
Patients must have fully recovered (grade \< 2) from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, eg, blood count criteria, the patient is considered to have recovered adequately
Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: See Developmental Therapeutics (DVL) homepage on the Children's Oncology Group (COG) members site for commercial and investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
Solid tumor patients: ≥ 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea). Please refer to the table of myelosuppressive/anticancer agents on the COG website
Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): ≥ 7 days after the last dose of agent. See the DVL homepage on the COG Members site for commercial and investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤ 1
Corticosteroids: If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid
Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (eg, pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
Interleukins, interferons and cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
Stem cell Infusions (with or without total body irradiation \[TBI\]):
Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: ≥ 84 days after infusion and no evidence of graft versus host disease (GVHD)
Autologous stem cell infusion including boost infusion: ≥ 30 days
Cellular therapy: ≥ 30 days after the completion of any type of cellular therapy (eg, modified T cells, natural killer \[NK\] cells, dendritic cells, etc.)
Radiotherapy (XRT)/external beam irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial bone marrow (BM) radiation
Radiopharmaceutical therapy (eg, radiolabeled antibody, lobenguane I-131 \[131I-MIBG\]): ≥ 42 days after systemically administered radiopharmaceutical therapy
Patients must not have received prior Bcl-xL specific therapy (e.g. navitoclax, DT2216). Prior therapy with irinotecan or other topoisomerase 1 inhibitors and/or other BH3 mimetics which are not Bcl-xL selective (e.g. venetoclax) are acceptable
For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) ≥ 1000/µL
For patients with solid tumors without known bone marrow involvement: Platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
A creatinine based on age/gender as follows:
1 to \< 2 years: Maximum serum creatinine (mg/dL) 0.6 (male), 0.6 (female)
2 to \< 6 years: Maximum serum creatinine (mg/dL) 0.8 (male), 0.8 (female)
6 to \< 10 years: Maximum serum creatinine (mg/dL) 1 (male), 1 (female)
10 to \< 13 years: Maximum serum creatinine (mg/dL) 1.2 (male), 1.2 (female)
13 to \< 16 years: Maximum serum creatinine (mg/dL) 1.5 (male), 1.4 (female)
16 to ≤ 39 years: Maximum serum creatinine (mg/dL) 1.7 (male), 1.4 (female)
OR a 24 hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2
OR a glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard). Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
Patients with solid tumors: Bilirubin (sum of conjugated + unconjugated or total) ≤ 1.5 x upper limit of normal (ULN) for age
Patients with solid tumors: Alanine aminotransferase (ALT) ≤ 3 x ULN, unless attributed to tumor involvement then ALT ≤ 5 x ULN
Note: For the purposes of this study the ULN for ALT is defined as 45 U/L
Patients with solid tumors: Aspartate aminotransferase (AST) ≤ 3 x ULN, unless attributed to tumor involvement then AST ≤ 5 x ULN
Note: For the purposes of this study the ULN for AST is defined as 50 U/L
Patients with solid tumors: Albumin ≥ 2 g/dL
Patients with solid tumors: International normalized ratio (INR) ≤ 2.5
Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days. If needed, evaluate use of enzyme-inducing anticonvulsants
Nervous system disorders (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5) resulting from prior therapy must be ≤ grade 2, with the exception of decreased tendon reflex (DTR). Patient with any grade of tendon reflex decrease are eligible

Exclusion

Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (eg, male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control. Patients who could become pregnant should use highly effective contraception during therapy and for 6 months after the last irinotecan dose or 120 days after the last dose of DT2216, whichever is longer. Patients with partners who could become pregnant should use condoms during therapy and for 3 months after the last dose irinotecan or 120 days after the last dose of DT2216, whichever is longer
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible
Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 14 days prior to study enrollment are not eligible
Patients with lymphoma are excluded
Patients who have an uncontrolled infection are not eligible
Patients with grade ≥ 2 diarrhea at baseline are not eligible
Patients who have received a prior solid organ transplantation are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Dedicated central nervous system (CNS) imaging is not required but patients with current active CNS metastasis whether symptomatic or discovered incidentally without clinical symptoms, are not eligible
Patients with grade \> 2 corrected QT interval (i.e. electrocardiogram \[EKG\] showing corrected QT interval \[QTc\] \> 480 ms) at baseline are not eligible
Surgical procedure
Central line placement, open or core needle biopsy of sites other than liver: \< 2 days prior to enrollment.
Open or laparoscopic biopsies or core needle biopsies of liver \< 7 days prior to enrollment.
All other surgeries \< 14 days prior to enrollment

What this trial measures

  • Incidence of adverse events (AEs)Up to 30 days after last dose of study drug

    AEs will be assessed and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. A descriptive summary of all toxicities will be reported.

  • Dose-limiting toxicity (DLT)Up to 21 days

    AEs will be assessed and graded using NCI CTCAE v5.0. A descriptive summary of all toxicities will be reported.

  • Maximum tolerated dose (MTD)/ recommended phase 2 doseUp to 21 days

    MTD will be defined as the maximum dose at which fewer than one-third of patients experience DLT during cycle 1 of therapy.

  • Area under the dose concentration curve of DT2216Up to 7 hours

    Median (minimum \[min\], maximum \[max\]) area under the dose concentration curve of DT2216 during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.

  • Clearance of DT2216Up to 7 hours

    Median (min, max) clearance of DT2216 during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.

  • Half-life of DT2216Up to 7 hours

    Median (min, max) Half-life of DT2216 during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.

  • Area under the dose concentration curve of irinotecanUp to 7 hours

    Median (min, max) area under the dose concentration curve of irinotecan during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.

  • Clearance of irinotecanUp to 7 hours

    Median (min, max) clearance of irinotecan during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.

  • Half-life of irinotecanUp to 7 hours

    Median (min, max) Half-life of irinotecan during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.

  • Overall response rate (ORR)At start of treatment until disease progression or recurrence up to 60 months

    ORR will be recorded from the start of the treatment until disease progression or recurrence. ORR of partial response, complete response or stable disease will be assessed according to Response Evaluation Criteria in Solid Tumors Criteria and will be reported descriptively.