LCB84 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors

What is the Purpose of this Study?

This study focuses on individuals who have metastatic cancer (cancer that has spread) that has not responded to standard treatments or for whom no effective therapy is available. The purpose of the study is to evaluate LCB84, a type of drug called a TROP2 (human trophoblastic cell surface antigen 2) drug-antibody conjugate. LCB84 is an experimental medicine and works by using TROP2 as a target to deliver chemotherapy directly to tumor cells, unlike regular chemotherapy that goes everywhere in the body. The goal of the first part of the study is to find the highest tolerable dose of LCB84 when given alone and in combination with a immunotherapy drug called pembrolizumab. The second part of the study aims to determine the effectiveness of LCB84 alone or in combination with pembrolizumab in the treatment of various types of cancer.


Eligibility

  • * Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
  • * Phase 2 Dose Expansion\*: select histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
  • \*expansion cohort indications to be prioritized based on data from Phase 1 dose escalation.
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Where can I participate?

  • Cedars-Sinai Cancer at Beverly Hills (THO) : Shannon Cyhan
  • Cedars-Sinai Cancer at SOCC : Shannon Cyhan


More about this Clinical Trial

What is the full name of this clinical trial?

LCB84-1001: A First -In-Human Phase 1/2, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination with Pembrolizumab, in Patients with Advanced Solid Tumors

Study Details
Disease Type/Condition

Anus, Brain and Nervous System, Breast, Cervix, Colon, Esophagus

Principal Investigator

Yuan, Yuan

Co-Investigators

Andrew Hendifar, Arsen Osipov, Bobbie Jo Rimel, David Hoffman, Edwin Posadas, Jeremy Lorber, Jin Sun Bitar, Jun Gong, Kamya Sankar, Karen Reckamp, Kevin Scher, Ronald Natale, Yuan Yuan

Age Group

Adult

Phase

I/II

IRB Number

STUDY00002944

ClinicalTrials.gov ID

NCT05941507

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org
Study Detail
Disease Type/Condition

Anus, Brain and Nervous System, Breast, Cervix, Colon, Esophagus

Principal Investigator

Yuan, Yuan

Age Group

Adult

Phase

I/II

IRB Number

LCB84-1001

ClinicalTrials.gov ID

NCT05941507

Key Eligibility
ClinicalTrials.gov

Contact
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org