A Phase 1 interventional study of RNDO-564 and Pembrolizumab in Non Small Cell Lung Cancer, Cervical Cancer and Head and Neck Squamous Cell Cancer, sponsored by Rondo Therapeutics. Enrolling by invitation at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Rondo Therapeutics · Phase 1, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 149 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →This is the only study on the registry with Rondo Therapeutics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
1) Eligible tumor types: Histologic documentation of incurable, locally advanced or metastatic solid tumors for which established standard systemic therapies are no longer effective (participant must have experienced progressive disease), are not tolerated, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds or have been declined by the participant, with these tumor subtypes:
A. Monotherapy and Combination Dose Escalation Arms:
B. Dose Optimization (Monotherapy and Combination Arms):
Participants may have had up to 2 prior MMAE-containing therapies, assuming any existing peripheral neuropathy is Grade 2 or less 2. Participants must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
3. Adequate organ function
Exclusion Criteria:
For Nectin-4 targeted agents (approved or investigational)
Single Agent Dose Level 1
Drug: RNDO-564
Single Agent Dose Level 2
Drug: RNDO-564
Single Agent Dose Level 3
Drug: RNDO-564
Single Agent Dose Level 4
Drug: RNDO-564
Single Agent Dose Level 5
Drug: RNDO-564
Single Agent Dose Level 6
Drug: RNDO-564
Single Agent Dose Level 7
Drug: RNDO-564
Single Agent Dose Level 8
Drug: RNDO-564
Single Agent Dose Level 9
Drug: RNDO-564
Combination Dose Escalation- Dose Level 1
Drug: RNDO-564 · Drug: Pembrolizumab
Combination Dose Escalation - Dose Level 2
Drug: RNDO-564 · Drug: Pembrolizumab
Single Agent Dose Optimization - Dose Level 1
Drug: RNDO-564
Single Agent Dose Optimization - Dose Level 2
Drug: RNDO-564
Combination Dose Optimization - Dose Level 1
Drug: RNDO-564 · Drug: Pembrolizumab
Combination Dose Optimization - Dose Level 2
Drug: RNDO-564 · Drug: Pembrolizumab
CD28 x Nectin-4 bispecific
Anti-PD-1 therapy
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
• Type, frequency, and severity of adverse events (AEs)
Time frame: From Day 1 to 90-days post last dose
Dose Optimization Arms: • Identify one or more recommended Phase 2 doses (RP2D)
To evaluate the totality of data
Time frame: From Day 1 up to 24 months
All Arms: To evaluate serum concentrations at specified timepoints of RNDO-564 as a single agent or in combination with pembrolizumab
Time frame: From Day 1 up to 25 months (inclusive of 30 day safety follow-up)
All Arms: Proportion of participants that develop anti-drug antibodies to RNDO-564
Time frame: Baseline (predose) up to 25 months (inclusive of 30 day safety follow-up)
All Arms: Evaluate the prevalence, incidence and impact of anti-drug antibodies to RNDO-564
Time frame: From Baseline (predose) up to 25 months (inclusive of the 30 day safety follow-up).
All Arms: Objective Response Rate Among Participants
Time frame: percentage of participants from Day 1 until the date of the first documented partial response or complete response assessed up to 24 months
All Arms: Duration of Response
Time frame: Time between the first partial response or complete response and the date of first documented progression or date of death, whichever came first, assessed up to 24 months
All Arms: Median Progression Free Survival Time Among Participants
Time frame: The number of months from Day 1 until the date of first documented progression or date of death, whichever came first, assessed up to 24 months
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→