A Study of DT2216 in Relapsed/Refractory Malignancies

Completed · Phase 1

Conditions studied: Solid Tumor, Hematologic Malignancy

In brief

A Phase 1, Open-Label, Dose Escalation, and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Clinical Activity of DT2216, an Antiapoptotic Protein Targeted Degradation Compound, in Subjects with Relapsed or Refractory Malignancies

Key facts

Study ID

NCT04886622

Run by

Dialectic Therapeutics, Inc

People needed

20

Starts

2021-08-25

Expected to finish

2024-06-30

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older on the day of signing informed consent.
• Provide written informed consent for the trial, including willingness to comply with all study related requirements.
• Histologically or cytologically confirmed solid tumor. Subjects with more than 1 primary malignancy may be considered upon review with the Sponsor's Medical Monitor
• Evidence of disease progression or inadequate response on the last regimen as assessed by the Investigator.
• Has exhausted all curative options or has a contraindication to approved therapies or generally recognized standard-of-care measures for the subject's cancer.
• Presence of measurable disease as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Has adequate organ functions as defined by the following laboratory parameters at baseline (laboratory parameters outside of these ranges that are deemed clinically insignificant should be discussed with the Medical Monitor): (a) Absolute neutrophil count ≥1.5 x 109/L; (b) hemoglobin ≥9 g/dL; (c) platelet count ≥100,000/mm3; (d) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN); (e) total bilirubin ≤ 1.5 x institutional ULN (exception: subjects with known Gilbert's syndrome and total bilirubin ≤3.0 x ULN at screening or anytime during the prior 6 months are eligible); (f) c) adequate renal function defined as calculated creatinine clearance >60 mL/min using the Cockcroft-Gault Method (Appendix 3); (g) acceptable coagulation parameters including international normalized ratio (INR) <1.5 and partial thromboplastin time (PTT) ≤ institutional ULN; (h) serum albumin ≥3.0 g/dL.
• Left ventricular ejection fraction of ≥50% as assessed by echocardiogram or multi-gated acquisition (MUGA) scan.
• Adequate washout from the following prior to first dose of study therapy: Palliative radiation ≥ 2 weeks; chemotherapy or targeted therapy ≥ 3 weeks or 5 half-lives; biologic therapy ≥ 4 weeks.
• Resolution to Grade ≤1 by the National Cancer Institute CTCAE, Version 5.0 (NCI-CTCAE v 5.0) of all clinically significant toxic effects of prior therapies.
• Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: (a) Not a woman of childbearing potential (WOCBP); (b) WOCBP who agrees to follow the contraceptive guidance during the study treatment period and for at least 120 days after the last dose of study treatment.
• Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving any dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Male subject is eligible to participate if he agrees to follow the acceptable contraceptive guidance during the study treatment period and for at least 120 days after the last dose of study treatment.

You may not qualify if…

• Diagnosis and Main Criteria for Inclusion:
• Subjects are eligible to be included in the study only if all of the following criteria are met:
• Inclusion Criteria
• Adults aged 18 years or older on the day of signing informed consent.
• Provide written informed consent for the trial, including willingness to comply with all study related requirements.
• Histologically or cytologically confirmed solid tumor. Subjects with more than 1 primary malignancy may be considered upon review with the Sponsor's Medical Monitor.
• Evidence of disease progression or inadequate response on the last regimen as assessed by the Investigator.
• Has exhausted all curative options or has a contraindication to approved therapies or generally recognized standard-of-care measures for the subject's cancer.
• Presence of measurable disease as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Has adequate organ functions as defined by the following laboratory parameters at baseline (laboratory parameters outside of these ranges that are deemed clinically insignificant should be discussed with the Medical Monitor): (a) Absolute neutrophil count ≥1.5 x 109/L; (b) hemoglobin ≥9 g/dL; (c) platelet count ≥100,000/mm3; (d) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN); (e) total bilirubin ≤ 1.5 x institutional ULN (exception: subjects with known Gilbert's syndrome and total bilirubin ≤3.0 x ULN at screening or anytime during the prior 6 months are eligible); (f) c) adequate renal function defined as calculated creatinine clearance >60 mL/min using the Cockcroft-Gault Method (Appendix 3); (g) acceptable coagulation parameters including international normalized ratio (INR) <1.5 and partial thromboplastin time (PTT) ≤ institutional ULN; (h) serum albumin ≥3.0 g/dL.
• Left ventricular ejection fraction of ≥50% as assessed by echocardiogram or MUGA scan.
• Adequate washout from the following prior to first dose of study therapy: Palliative radiation ≥ 2 weeks; chemotherapy or targeted therapy ≥ 3 weeks or 5 half-lives; biologic therapy ≥ 4 weeks.
• Resolution to Grade ≤1 by the National Cancer Institute CTCAE, Version 5.0 (NCI-CTCAE v 5.0) of all clinically significant toxic effects of prior therapies.
• Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: (a) Not a woman of childbearing potential (WOCBP); (b) WOCBP who agrees to follow the contraceptive guidance during the study treatment period and for at least 120 days after the last dose of study treatment.
• Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving any dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Male subject is eligible to participate if he agrees to follow the acceptable contraceptive guidance during the study treatment period and for at least 120 days after the last dose of study treatment.
• Exclusion Criteria
• Received any BCL-XL directed therapy.
• Administration of any blood products within the 30 days preceding the planned administration of study therapy.
• History of clinically significant bleeding and/or bleeding predisposition.
• Significant liver insufficiency defined as Child-Pugh Class B or C
• Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). Strong CYP3A inhibitors and inducers should be discontinued at least 2 weeks prior to the first dose of DT2216 (Appendix 5).
• Known active central nervous system (CNS) metastases/and or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable without evidence of progression via imaging for at least 4 weeks prior to first dose of study therapy, are not receiving pharmacologic doses of glucocorticoids and are without evidence of neurological symptoms. Carcinomatous meningitis is excluded regardless of clinical stability.
• Requiring anticoagulation for any reason (subjects who are on anticoagulants during the screening period and are candidates for discontinuation can be considered).

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• Mays Cancer Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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