DT2216 Clinical Trials

Size	Price	Qty
1mg	USD 399
5mg	USD 970

Clinical Trials

DT2216 is currently being evaluated in several Phase 1 and Phase 1/2 clinical trials targeting advanced solid tumors, hematologic malignancies, platinum-resistant ovarian carcinoma, and pediatric recurrent or refractory solid neoplasms, including fibrolamellar carcinoma. Sponsored by biopharmaceutical industry entities such as Dialectic Therapeutics, cooperative research networks like the Children's Oncology Group, and academic investigators, these studies encompass completed, suspended, and actively recruiting protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06620302	SUSPENDED	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	Children's Oncology Group	2025-06-12	PHASE1; PHASE2
NCT06964009	RECRUITING	Ovarian Cancer; Ovarian Carcinoma; Recurrent Ovary Cancer; Recurrent Platinum-Resistant Ovarian Carcinoma	Elizabeth Stover, MD, PhD	2025-09-22	PHASE1
NCT04886622	COMPLETED	Solid Tumor; Hematologic Malignancy	Dialectic Therapeutics, Inc	2021-08-25	PHASE1
NCT04886622	Completed	Solid Tumor\|Hematologic Malignancy	Dialectic Therapeutics Inc	2021-08-25	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the DT2216 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a proteolysis targeting chimera (PROTAC), DT2216 selectively targets BCL-XL for ubiquitin-proteasome-mediated degradation, thereby dismantling BCL-XL-mediated anti-apoptotic signaling. This targeted destruction triggers apoptotic cell death in BCL-XL-dependent tumor cells while sparing platelets, providing a mechanistic rationale for its clinical evaluation against solid tumors, hematologic malignancies, and platinum-resistant ovarian carcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).