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A robust pipeline of ADCs for the treatment of hematological cancers and solid tumors

Strategic target selection for pyrrolobenzodiazepine (PBD)-based antibody drug conjugates (ADCs) and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematologic and solid tumor cancers with significant unmet need.

The agents represented in this pipeline chart are investigational. Efficacy and safety have not yet been established.

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

ZYNLONTA

ZYNLONTA® (Loncastuximab Tesirine-lpyl) Targeting CD19

LOTIS-2 in 3L+ r/r DLBCL

ClinicaTrials.gov identifier: NCT03589469

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

FDA Approved

LOTIS-5 with rituximab in r/r NTE DLBCL

ClinicalTrials.gov identifier: NCT04384484

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

Confirmatory

LOTIS-7 in non-Hodgkin Lymphoma

ClinicaTrials.gov identifier: NCT04970901

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

PBD-Based

ADCT-602*
Targeting CD22

Acute Lymphoblastic Leukemia

ClinicalTrials.gov identifier: NCT03698552

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

ADCT-901
Targeting KAAG1

Various Solid Tumors

ClinicaTrials.gov identifier: NCT04972981

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

ADCT-601
Targeting AXL

Various Solid Tumors

ClinicaTrials.gov identifier: NCT05389462

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

Single-Agent Arm

Combination Arm

Expanded Platform

Multiple Programs

Preclinical

Phase 1a

Phase 1b

Phase 2

Phase 3/
Confirmatory

* The ADCT-602 trial is being led by the University of Texas MD Anderson Cancer Center.

For more information on our clinical trials visit adctmedical.com

Loncastuximab tesirine-lpyl

Loncastuximab tesirine-lpyl is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and is conjugated through a linker to a PBD–dimer toxin. Once bound to a CD19-expressing cell, loncastuximab tesirine-lpyl is internalized into the cell, where enzymes release the PBD-based warhead. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication. This ultimately results in cell death.

The LOTIS clinical trial program

Lotis 1, Image

[402-101] – A Phase 1 Dose-escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non-Hodgkin Lymphoma (B-NHL)

NCT02669017
COMPLETED

Lotis 2, Image

[402-201] – A Phase 2 Open-label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine-lpyl in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

NCT03589469
ACTIVE, NOT RECRUITING

Lotis 5, Image

[402-311] – A Phase 3 Randomized Study of Loncastuximab Tesirine-lpyl Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

NCT04384484
RECRUITING

A Phase 1b, Open-label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine-lpyl in Combination With Other Anticancer Agents in Patients with Relapsed or Refractory B-cell Lineage Non-Hodgkin Lymphoma (B-NHL)

NCT04970901
RECRUITING

ADCT-602 targeting CD22

ADCT-602 is an ADC composed of a monoclonal antibody that binds to CD22 conjugated to a PBD–dimer toxin. Once bound to a CD22-expressing cell, ADCT-602 is internalized into the cell where enzymes release the PBD-based warhead. CD22 is an attractive and clinically validated ADC target. CD22 is highly expressed on most malignant B-cells, including expression in more than 90% of patients with B-cell acute lymphoblastic leukemia (ALL).

ADCT-602 is being evaluated in a phase I/II clinical trial in patients with relapsed or refractory B-cell ALL (NCT03698552). The trial is being led by The University of Texas MD Anderson Cancer Center.

ADCT-602 targets CD22, Diagram

Mipasetamab uzoptirine (ADCT-601)

Mipasetamab uzoptirine (ADCT-601) is an ADC composed of a humanized monoclonal antibody that binds to human AXL (licensed from BerGenBio), conjugated using GlycoConnect™ technology (licensed from Synaffix BV) to a linker with the PBD–dimer toxin SG3199. Once bound to a cell that expresses the AXL protein, Mipasetamab uzoptirine (ADCT-601) is internalized, the PBD is released and diffuses into the nucleus where it binds the DNA. AXL is a promising target for an ADC approach, as it is overexpressed in many solid tumors (e.g., sarcoma, lung, breast, prostate, pancreas, glioma, and esophageal) and hematological malignancies (e.g., acute and chronic myeloid leukemia).

ADCT-601 Targeting AXL, Diagram

ADCT-901 targeting KAAG1

ADCT-901 is an ADC composed of a humanized monoclonal antibody (3A4) directed against human KAAG1 and conjugated through a cathepsin-cleavable linker to SG3199, a PBD–dimer cytotoxin. KAAG1 is an attractive novel tumor target for ADC development because it has high expression in tumor cell lines, including ovarian cancer and triple negative breast cancer, and low expression on non-cancerous cells from the same tissue. The ADC is internalized and has been shown to be an effective cytotoxin in various preclinical models.

ADCT-901 is being developed for the treatment of advanced solid tumors with high unmet medical needs, including platinum resistant ovarian cancer and triple negative breast cancer.

KAAG1

For more information on our clinical trials visit adctmedical.com