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

NCT04799054 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor
  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Head and Neck Squamous Cell Carcinoma HNSCC
  • HPV-associated Cancers
  • Neoadjuvant Melanoma
  • Neoadjuvant Cutaneous Squamous Cell Carcinoma (cSCC)

Interventions

DRUG

TransCon TLR7/8 Agonist

TransCon TLR7/8 Agonist will be administered as an IT injection

DRUG

Pembrolizumab

Pembrolizumab will be administered IV

Sponsors & Collaborators

  • Ascendis Pharma Oncology Division A/S

    lead INDUSTRY

Principal Investigators

  • Ascendis Oncology Clinical Trials · Ascendis Oncology Clinical Trials

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2025-12-02
Completion
2025-12-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Netherlands
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04799054 on ClinicalTrials.gov