A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05581004
• Collaborator: (none)
• Enrollment: 365
• Locations: 7
• Arms: 4
• Anticipated Duration (Months): 36.4
• Patients Per Site: 52.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced or Metastatic Solid Tumors; NSCLC; HNSCC; Melanoma; TNBC; Esophageal Cancer; Gastric Cancer; Cervical Cancer; Urothelial Carcinoma; Clear Cell RCC; HCC	Drug: RO7502175; Drug: Atezolizumab	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 365 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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 Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
• Actual Study Start Date: Oct 20, 2022
• Anticipated Primary Completion Date: Jul 31, 2025
• Anticipated Study Completion Date: Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: RO7502175; RO7502175 will be administered as per the schedules specified in the respective arms.
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.	Drug: RO7502175; RO7502175 will be administered as per the schedules specified in the respective arms.
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.	Drug: RO7502175; RO7502175 will be administered as per the schedules specified in the respective arms.; Drug: Atezolizumab; Atezolizumab will be administered as per the schedules specified in the respective arms.
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, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.	Drug: RO7502175; RO7502175 will be administered as per the schedules specified in the respective arms.; Drug: Atezolizumab; Atezolizumab will be administered as per the schedules specified in the respective arms.

Outcome Measures

Primary Outcome Measures

1. Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs) [From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)]

2. Phase Ib: Number of Participants with DLTs [From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)]

3. Phase Ia: Number of Participants with Treatment Emergent Adverse Events [Up to approximately 5 years]

4. Phase Ib: Number of Participants with Treatment Emergent Adverse Events [Up to approximately 5 years]

Secondary Outcome Measures

1. Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175 [From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)]

2. Phase Ia and Phase Ib: Objective Response Rate (ORR) [From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)]

3. Phase Ia and Phase Ib: Duration of Response (DOR) [From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)]

4. Phase Ia and Phase Ib: Progression Free Survival (PFS) [From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)]

5. Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175 [From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Colorado	Aurora	Colorado	United States	80045
2	Florida Cancer Specialists - Sarasota	Sarasota	Florida	United States	34232
3	Winship Cancer Institute	Atlanta	Georgia	United States	30322
4	The West Clinic - Memphis (Union Ave)	Germantown	Tennessee	United States	38138
5	SCRI Tennessee Oncology Nashville	Nashville	Tennessee	United States	37203
6	Monash Health Monash Medical Centre	Clayton	Victoria	Australia	3168
7	Linear Clinical Research Ltd	Nedlands	Western Australia	Australia	6009

Sponsors and Collaborators

• Genentech, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT05581004
• Other Study ID Numbers: GO43860; 2021-006708-34
• First Posted: Oct 14, 2022
• Last Update Posted: Jan 6, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atezolizumab

Study Results

No Results Posted as of Jan 6, 2023