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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RNDO-564 — DRUG
  CD28 x Nectin-4 bispecific
• Pembrolizumab — DRUG
  Anti-PD-1 therapy

Study Details

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.

Key Dates

Start date

Nov 17, 2025

Status verified

Jun 2026

Primary completion

Feb 28, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

149 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Single Agent Dose Level 1
  Single Agent Dose Level 1
• Experimental: Single Agent Dose Level 2
  Single Agent Dose Level 2
• Experimental: Single Agent Dose Level 3
  Single Agent Dose Level 3
• Experimental: Single Agent Dose Level 4
  Single Agent Dose Level 4
• Experimental: Single Agent Dose Level 5
  Single Agent Dose Level 5
• Experimental: Single Agent Dose Level 6
  Single Agent Dose Level 6
• Experimental: Single Agent Dose Level 7
  Single Agent Dose Level 7
• Experimental: Single Agent Dose Level 8
  Single Agent Dose Level 8
• Experimental: Single Agent Dose Level 9
  Single Agent Dose Level 9
• Experimental: Combination Dose Escalation- Dose Level 1
  Combination Dose Escalation- Dose Level 1
• Experimental: Combination Dose Escalation - Dose Level 2
  Combination Dose Escalation - Dose Level 2
• Experimental: Single Agent Dose Optimization - Dose Level 1
  Single Agent Dose Optimization - Dose Level 1
• Experimental: Single Agent Dose Optimization - Dose Level 2
  Single Agent Dose Optimization - Dose Level 2
• Experimental: Combination Dose Optimization - Dose Level 1
  Combination Dose Optimization - Dose Level 1
• Experimental: Combination Dose Optimization- Dose Level 2
  Combination Dose Optimization - Dose Level 2

Primary Outcome Measure

All Arms: - Proportion of participants with adverse events (including dose limiting toxicities) as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [ Time Frame: From Day 1 to 90-days post last dose ]

Locations (11)

Find similar trials in San Francisco, CA

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