Rovalpituzumab Tesirine

Summary

Rovalpituzumab Tesirine (CHEMBL3990011) is a phase-3 clinical-stage antibody drug conjugate; indicated across 3 conditions including small cell lung carcinoma and neoplasm; with CIViC clinical evidence for 1 variant-indication association (e.g. DLL3 Expression in lung small cell carcinoma).

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody drug conjugate
• Indications: 3 conditions
• Clinical trials: 14
• Precision-oncology evidence (CIViC): 1 variant–indication association

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3990011
Name	Rovalpituzumab Tesirine
Type	Antibody drug conjugate
Max phase	3

Also known as: Rovalpituzumab tesirina, Rovalpituzumab tesirine, Sc 002, SC-002, SC-16LD6.5, SC0002, SC16LD6.5, ROVALPITUZUMAB TESIRINE

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
small cell lung carcinoma	3	MONDO:0008433	EFO:0000702
neoplasm	2	MONDO:0005070	EFO:0000616

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 14.

Phase distribution

Phase	Trials
PHASE1	5
PHASE3	3
PHASE1/PHASE2	3
PHASE2	2
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03033511	PHASE3	TERMINATED	A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
NCT03061812	PHASE3	COMPLETED	Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
NCT03334487	PHASE3	WITHDRAWN	Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
NCT01901653	PHASE1/PHASE2	COMPLETED	Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
NCT02674568	PHASE2	COMPLETED	Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer
NCT02709889	PHASE1/PHASE2	TERMINATED	Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
NCT03026166	PHASE1/PHASE2	TERMINATED	A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
NCT03543358	PHASE2	COMPLETED	A Long-Term Study of Rovalpituzumab Tesirine
NCT02500914	PHASE1	TERMINATED	SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
NCT02819999	PHASE1	TERMINATED	A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Extensive Stage Small Cell Lung Cancer
NCT02874664	PHASE1	COMPLETED	A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
NCT03000257	PHASE1	COMPLETED	A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors
NCT03086239	PHASE1	COMPLETED	A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
NCT03503890	Not specified	NO_LONGER_AVAILABLE	Expanded Access to Rovalpituzumab Tesirine

Clinical evidence (CIViC)

Variant × indication × effect (1 predictive associations from 2 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
DLL3 Expression	Lung Small Cell Carcinoma	Sensitivity/Response	Rovalpituzumab Tesirine	CIViC B	EID5919 +1

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).