TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers

NCT04485013 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-18

No results posted yet for this study

Summary

TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.

Conditions

Interventions

DRUG

TTX-080

Variable dose (Q3W)

DRUG

TTX-080

Specified dose (Q3W)

DRUG

pembrolizumab

Specified dose (Q3W)

DRUG

cetuximab

Specified dose on specified days

DRUG

FOLFIRI

Specified dose (Q2W)

DRUG

cetuximab

Specified dose (Q2W)

DRUG

TTX-080

Specified dose (Q2W)

Sponsors & Collaborators

  • Tizona Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2027-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04485013 on ClinicalTrials.gov