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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05581004




Registration number
NCT05581004
Ethics application status
Date submitted
12/10/2022
Date registered
14/10/2022
Date last updated
22/11/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
2021-006708-34
Secondary ID [2] 0 0
GO43860
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Solid Tumors 0 0
NSCLC 0 0
HNSCC 0 0
Melanoma 0 0
TNBC 0 0
Esophageal Cancer 0 0
Gastric Cancer 0 0
Cervical Cancer 0 0
Colorectal Cancer 0 0
Urothelial Carcinoma 0 0
Clear Cell RCC 0 0
HCC 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7502175
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Pembrolizumab

Experimental: Phase Ia: Dose Escalation - Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Experimental: Phase Ia: Expansion - Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Experimental: Phase Ib: Dose Escalation - Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Experimental: Phase Ib: Expansion - Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.


Treatment: Drugs: RO7502175
RO7502175 will be administered as per the schedules specified in the respective arms.

Treatment: Drugs: Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered as per the schedules specified in the respective arms.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
Primary outcome [2] 0 0
Phase Ib: Number of Participants with DLTs
Timepoint [2] 0 0
From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
Primary outcome [3] 0 0
Phase Ia: Number of Participants with Treatment Emergent Adverse Events
Timepoint [3] 0 0
Up to approximately 5 years
Primary outcome [4] 0 0
Phase Ib: Number of Participants with Treatment Emergent Adverse Events
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175
Timepoint [1] 0 0
From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)
Secondary outcome [2] 0 0
Phase Ia and Phase Ib: Objective Response Rate (ORR)
Timepoint [2] 0 0
From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Secondary outcome [3] 0 0
Phase Ia and Phase Ib: Duration of Response (DOR)
Timepoint [3] 0 0
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Secondary outcome [4] 0 0
Phase Ia and Phase Ib: Progression Free Survival (PFS)
Timepoint [4] 0 0
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Secondary outcome [5] 0 0
Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175
Timepoint [5] 0 0
From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)

Eligibility
Key inclusion criteria
* Life expectancy 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 (RECIST) Version 1.1
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
* Tumor Specimen availability
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, 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, or radiotherapy, within 3 weeks prior to initiation of study treatment
* Active hepatitis B or C 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 RO7502175 infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre; St Vincents Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Monash Health Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Edegem
Country [12] 0 0
Belgium
State/province [12] 0 0
Liège
Country [13] 0 0
Belgium
State/province [13] 0 0
Wilrijk
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Netherlands
State/province [19] 0 0
Groningen
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Malaga
Country [23] 0 0
Spain
State/province [23] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 or pembrolizumab 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, colorectal cancer (CRC), 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.
Trial website
https://clinicaltrials.gov/study/NCT05581004
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO43860 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05581004