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Trial Summary

TransCon TLR7/8 Agonist is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This Phase 1/2 study will evaluate TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Participants will receive intratumoral (IT) injection of TransCon TLR7/8 Agonist every cycle. The primary objectives are to evaluate safety and tolerability, and define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab.

Acronym:

TCTLR-101

ACTRN/NCT /ethics:

NCT04799054

Scientific title:

A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Sponsor / Cooperative group:

Ascendis Pharma A/S ( Ascendis Pharma Oncology Division A/S )

Trial & Patient Characteristics

Cancer TypeAll
Trial TypeTreatment
PhasePhase I & Phase II
Age Range18 years and older
SexAll
Tumour Stream -
Cancer Stage-
Anticipated Start Date2021-03-18
Anticipated End Date2026-03-01

Participating Hospitals

HospitalSouthern Oncology Clinical Research Unit
Clinical Trial CoordinatorMeggan O'Riley
EmailMeggan.Oriley@socru.org.au
Phone0491 679 039
Principal InvestigatorGanessan Kichenadasse
Recruitment StatusRecruiting