Trials / Enrolling By Invitation

Enrolling By InvitationNCT07218003

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

An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression

Status: Enrolling By Invitation
Phase: Phase 1
Study type: Interventional
Enrollment: 149 (estimated)

Sponsor: Rondo Therapeutics · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

The study will consist of four stages: 1) single agent dose escalation, 2) single agent dose optimization, 3) combination dose escalation and 4) combination dose optimization. Stages 1 and 3 are dose escalation to investigate the safety and tolerability of increasing doses of RNDO-564 as a single agent and in combination with standard pembrolizumab treatment. Participants will be enrolled who have one of the following advanced solid tumors associated with Nectin-4: locally advanced/metastatic urothelial cancer (la/m UC), cervical cancer (CC), head and neck cancer (HNSCC), esophageal cancer (EC), gastric (GC) and gastroesophageal junction cancer (GEJ), triple negative breast cancer (TNBC), and non-small cell lung cancer (NSCLC). The cancer must not have responded well to previous cancer treatments. Stages 1, and 3 will be non-randomized. Stages 2 (i.e., RNDO-564 single agent) and 4 (i.e., RNDO-564 in combination with pembrolizumab) are dose optimization and proof-of-concept stages to further investigate the safety and tolerability of at least 2 doses of RNDO-564 as a single agent and in combination with standard pembrolizumab treatment, and to investigate preliminary anti-tumor activity. Stages 2 and 4 will enroll participants with advanced urothelial cancer only. The cancer must not have responded well to previous cancer treatments. Participants will be randomized (1:1) into one of two arms which will evaluate two dose levels (as selected from Stages 1 and 3). The study consists of a screening period, a treatment period, an end of treatment visit, a safety follow-up visit, and 60 and 90 days telephone follow-up after ending treatment. The treatment period will last for a maximum of 2 years.

Conditions

Interventions

Type	Name	Description
DRUG	RNDO-564	CD28 x Nectin-4 bispecific
DRUG	Pembrolizumab	Anti-PD-1 therapy

Timeline

Start date: 2025-11-17
Primary completion: 2029-02-28
Completion: 2029-03-31
First posted: 2025-10-20
Last updated: 2026-03-23

Locations

7 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07218003. Inclusion in this directory is not an endorsement.