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Evaluating RO7502175 for advanced solid tumors

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1 Interventional Genentech, Inc. · NCT05581004

This study is testing a new treatment called RO7502175 for adults with advanced solid tumors to see how safe it is and how well it works, both on its own and with other cancer drugs.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. Industry-sponsored
Drugs / interventionspembrolizumab, atezolizumab, chemotherapy
Locations41 sites (San Francisco, California and 40 other locations)
Trial IDNCT05581004 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, pharmacokinetics, and anti-tumor activity of RO7502175, both as a standalone treatment and in combination with checkpoint inhibitors like atezolizumab and pembrolizumab. It targets adult participants with locally advanced or metastatic solid tumors, including various types of cancer such as non-small-cell lung cancer and triple-negative breast cancer. The study will be conducted in two stages: dose escalation and dose expansion, allowing researchers to determine the optimal dosing and effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically confirmed locally advanced or metastatic solid tumors and an ECOG performance status of 0 or 1.

Not a fit: Patients who are currently undergoing other anti-cancer therapies or have active infections such as hepatitis or HIV may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat advanced solid tumors.

How similar studies have performed: Other studies involving checkpoint inhibitors have shown promising results, suggesting that this approach may be effective, although the specific combination with RO7502175 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
* Tumor specimen availability

Exclusion Criteria:

* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis
* Positive test for human immunodeficiency virus (HIV) infection
* Acute or chronic active Epstein-Barr virus (EBV) infection at screening
* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation

Where this trial is running

San Francisco, California and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced or Metastatic Solid TumorsNSCLCHNSCCMelanomaTNBCEsophageal CancerGastric CancerCervical Cancer
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.