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Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies

NCT03881488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-17

No results posted yet for this study

Summary

This is a Phase 1, open-label, first-in-human study of CTX-471 administered as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 treatment arms (Monotherapy Arm 1 and Combination Arm 2). Each arm will have two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.

Conditions

Interventions

DRUG

CTX-471

IV infusion every 2 weeks

DRUG

Pembrolizumab (KEYTRUDA®)

IV infusion every 6 weeks

Sponsors & Collaborators

  • IQVIA Pty Ltd

    collaborator INDUSTRY

  • Merck, Sharp & Dohme, LLC, Rahway, NJ USA

    collaborator UNKNOWN

  • Compass Therapeutics

    lead INDUSTRY

Principal Investigators

  • Thomas Scheutz, MD, PhD · Compass 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
2019-05-17
Primary Completion
2025-05-21
Completion
2025-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03881488 on ClinicalTrials.gov