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A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

NCT05753722 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-02-23

No results posted yet for this study

Summary

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.

Conditions

  • Advanced or Metastatic Solid Tumors
  • Non Small Cell Lung Cancer
  • NSCLC

Interventions

BIOLOGICAL

PRTH-101

PRTH-101 is a humanized immunoglobulin gamma-1 (IgG1) monoclonal antibody

BIOLOGICAL

Pembrolizumab

PRTH-101 in combination with Pembrolizumab

Sponsors & Collaborators

  • Incendia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Joseph Paul Eder, MD · Incendia Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05753722 on ClinicalTrials.gov