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A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

NCT07218003 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2026-05-04

No results posted yet for this study

Summary

The main goal of this study is to evaluate how safe and tolerable RNDO-564 is and to identify the best dose of RNDO-564 as a single agent and in combination with pembrolizumab. The study is focused on participants with certain solid tumors that are in an advanced stage and have certain tumor makers. This will be done by measuring the side effects that participants experience and how severe they are. Additionally, the study will evaluate how RNDO-564 moves into, through, and out of the body and how the treatment affects the body.

The second goal of this study is to evaluate how well RNDO-564 works by itself or in combination with pembrolizumab at treating participants' cancer. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured.

Participants will take RNDO-564 weekly on Days 1, 8 and 15 of a 21 day cycle. Participants in the combination arms will take RNDO-564 as described with pembrolizumab every 3 weeks.

Conditions

  • Non Small Cell Lung Cancer
  • Cervical Cancer
  • Head and Neck Squamous Cell Cancer
  • Triple Negative Breast Cancer (TNBC)
  • Urothelial Carcinoma Bladder
  • Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Esophageal Squamous Cell Cancer
  • Gastric Cancer
  • Cancer
  • Solid Tumors (Phase 1)

Interventions

DRUG

RNDO-564

CD28 x Nectin-4 bispecific

DRUG

Pembrolizumab

Anti-PD-1 therapy

Sponsors & Collaborators

  • Rondo Therapeutics

    lead INDUSTRY

Principal Investigators

  • Thomas Manley, MD · Rondo 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
2025-11-17
Primary Completion
2029-02-28
Completion
2029-03-31
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 NCT07218003 on ClinicalTrials.gov