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Non Small Cell Lung CancerPhase 1NCT07218003

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

A Phase 1 study testing RNDO-564 and Pembrolizumab in people with Non Small Cell Lung Cancer and Cervical Cancer, run by Rondo Therapeutics at 11 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RNDO-564 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
11 sitesUnited States
Study dates
17 Nov 2025to 31 Mar 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Monotherapy and Combination Dose Escalation Arms:
  • RR la/mUC: Participants with urothelial cancer (transitional cell) with squamous differentiation or mixed cell types are eligible. Participants with upper tract disease, e.g., involving ureters, or renal pelvis, are eligible. Participants may have had up to 2 prior monomethyl auristatin E (MMAE)-containing therapies, assuming any existing peripheral neuropathy is Grade 2 or less.
  • NSCLC
  • HNSCC
  • CC
Show all 13Show fewer
  • GC and GEJ
  • EC
  • TNBC
  • Dose Optimization (Monotherapy and Combination Arms):
  • Limited to participants who have RR la/mUC,
  • 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

Who cannot join

  • For Nectin-4 targeted agents (approved or investigational)
  • > one prior Nectin-4 targeted agents
  • Peripheral neuropathy > Grade 2
  • Participants with a history of, or with active, inflammatory skin disease, such as eczema, psoriasis that required or currently require biologics or oral steroids to control disease are ineligible.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

United States11 sites

  • START Midwest

    Grand Rapids, Michigan, 49546

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Carolina Biooncology

    Huntersville, North Carolina, 28078

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Sarah Cannon Research Institute, LLD

    Nashville, Tennessee, 37203

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • START Center for Cancer Research

    San Antonio, Texas, 78229

  • UCSF Medical Center

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • START Mountain Region

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
RNDO-564, Pembrolizumab
Keywords
RNDO-564-001, bladder cancer, bispecific antibody, solid tumors, Nectin-4, dose escalation, Phase 1/1b, CD28 x Nectin-4 bispecific, T-cell engager, CD28 costimulation
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Stomach Neoplasms, Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RNDO-564Drug

    CD28 x Nectin-4 bispecific

  • PembrolizumabDrug

    Anti-PD-1 therapy

Study groups in NCT07218003
Study groupRoleWhat they receive
Single Agent Dose Level 1ExperimentalSingle Agent Dose Level 1
Receives: Drug: RNDO-564
Single Agent Dose Level 2ExperimentalSingle Agent Dose Level 2
Receives: Drug: RNDO-564
Single Agent Dose Level 3ExperimentalSingle Agent Dose Level 3
Receives: Drug: RNDO-564
Single Agent Dose Level 4ExperimentalSingle Agent Dose Level 4
Receives: Drug: RNDO-564
Single Agent Dose Level 5ExperimentalSingle Agent Dose Level 5
Receives: Drug: RNDO-564
Single Agent Dose Level 6ExperimentalSingle Agent Dose Level 6
Receives: Drug: RNDO-564
Single Agent Dose Level 7ExperimentalSingle Agent Dose Level 7
Receives: Drug: RNDO-564
Single Agent Dose Level 8ExperimentalSingle Agent Dose Level 8
Receives: Drug: RNDO-564
Single Agent Dose Level 9ExperimentalSingle Agent Dose Level 9
Receives: Drug: RNDO-564
Combination Dose Escalation- Dose Level 1ExperimentalCombination Dose Escalation- Dose Level 1
Receives: Drug: RNDO-564; Drug: Pembrolizumab
Combination Dose Escalation - Dose Level 2ExperimentalCombination Dose Escalation - Dose Level 2
Receives: Drug: RNDO-564; Drug: Pembrolizumab
Single Agent Dose Optimization - Dose Level 1ExperimentalSingle Agent Dose Optimization - Dose Level 1
Receives: Drug: RNDO-564
Single Agent Dose Optimization - Dose Level 2ExperimentalSingle Agent Dose Optimization - Dose Level 2
Receives: Drug: RNDO-564
Combination Dose Optimization - Dose Level 1ExperimentalCombination Dose Optimization - Dose Level 1
Receives: Drug: RNDO-564; Drug: Pembrolizumab
Combination Dose Optimization- Dose Level 2ExperimentalCombination Dose Optimization - Dose Level 2
Receives: Drug: RNDO-564; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: From Day 1 to 90-days post last dose

  2. Dose Optimization Arms: • Identify one or more recommended Phase 2 doses (RP2D)

    To evaluate the totality of data

    Measured: From Day 1 up to 24 months

Secondary outcomes (6)

  1. All Arms: To evaluate serum concentrations at specified timepoints of RNDO-564 as a single agent or in combination with pembrolizumab

    Measured: From Day 1 up to 25 months (inclusive of 30 day safety follow-up)

  2. All Arms: Proportion of participants that develop anti-drug antibodies to RNDO-564

    Measured: Baseline (predose) up to 25 months (inclusive of 30 day safety follow-up)

  3. All Arms: Evaluate the prevalence, incidence and impact of anti-drug antibodies to RNDO-564

    Measured: From Baseline (predose) up to 25 months (inclusive of the 30 day safety follow-up).

  4. All Arms: Objective Response Rate Among Participants

    Measured: percentage of participants from Day 1 until the date of the first documented partial response or complete response assessed up to 24 months

  5. All Arms: Duration of Response

    Measured: 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

  6. All Arms: Median Progression Free Survival Time Among Participants

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2025
  2. Study start17 Nov 2025
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
149 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218003
Sponsor's protocol ID
RNDO-564-001
Status last verified
Jun 2026
First submitted
14 Oct 2025
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RNDO-564 and Pembrolizumab in people with Non Small Cell Lung Cancer and Cervical Cancer, run by Rondo Therapeutics at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07218003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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