Phase Ib: Dose Escalation for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Melanoma+10 More
Atezolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

Eligible Conditions
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Melanoma
  • HCC
  • Metastatic or Locally Advanced Solid Tumors
  • Transitional Cell, Carcinoma
  • TNBC
  • Cervical Cancers
  • HNSCC
  • Clear Cell RCC
  • Esophageal Neoplasms Malignant
  • Malignant Neoplasm of Stomach

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Melanoma

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Up to approximately 5 years

Year 5
Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175
Year 5
Phase Ia and Phase Ib: Duration of Response (DOR)
Phase Ia and Phase Ib: Progression Free Survival (PFS)
Year 5
Serum
Year 5
Phase Ia and Phase Ib: Objective Response Rate (ORR)
Day 21
Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)
Phase Ib: Number of Participants with DLTs
Year 5
Phase Ia: Number of Participants with Treatment Emergent Adverse Events
Phase Ib: Number of Participants with Treatment Emergent Adverse Events

Trial Safety

Safety Progress

1 of 3

Other trials for Melanoma

Trial Design

4 Treatment Groups

Phase Ib: Dose Escalation
1 of 4
Phase Ia: Dose Escalation
1 of 4
Phase Ia: Expansion
1 of 4
Phase Ib: Expansion
1 of 4
Experimental Treatment

365 Total Participants · 4 Treatment Groups

Primary Treatment: Phase Ib: Dose Escalation · No Placebo Group · Phase 1

Phase Ib: Dose EscalationExperimental Group · 2 Interventions: Atezolizumab, RO7502175 · Intervention Types: Drug, Drug
Phase Ia: Dose Escalation
Drug
Experimental Group · 1 Intervention: RO7502175 · Intervention Types: Drug
Phase Ia: Expansion
Drug
Experimental Group · 1 Intervention: RO7502175 · Intervention Types: Drug
Phase Ib: ExpansionExperimental Group · 2 Interventions: Atezolizumab, RO7502175 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2015
Completed Phase 4
~7500

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 5 years

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,487 Previous Clinical Trials
563,614 Total Patients Enrolled
34 Trials studying Melanoma
1,621 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 12 weeks from last treatment.\n
You have a performance status of 0 or 1.
You have measurable disease according to RECIST Version 1.1.
You have a histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.