A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.

Solid Tumors Clinical Trial

Official title:

An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642365
• Other study ID #: BP42595
• Secondary ID: 2020-003164-82
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2021
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.

Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.

• Measurable disease according to RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

• Able to provide the most recent archival tumor tissue samples.

• Adequate cardiovascular, haematological, liver and renal function.

• Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.

• Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.

• Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

Exclusion Criteria:

• Pregnancy, lactation, or breastfeeding.

• Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.

• History or clinical evidence of central nervous system (CNS) primary tumors or metastases.

• Participants with another invasive malignancy in the last two years.

• Participants with known active or uncontrolled infection.

• Positive HIV test at screening.

• Positive for Hepatitis B and C.

• Vaccination with live vaccines within 28 days prior to C1D1.

• Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion.

• Participants with wound healing complications.

• Dementia or altered mental status that would prohibit informed consent.

• History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).

• Active or history of autoimmune disease or immune deficiency.

• Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.

• Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.

• Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• RO7296682
RO7296682 will be administered as per the schedules specified in the respective arms.
• Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.

Locations

Country	Name	City	State
Australia	Peter Maccallum Cancer Institute; Clinical Trial Unit	Melbourne	Victoria
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	BC Cancer Agency - Vancouver	Vancouver	British Columbia
Denmark	Rigshospitalet; Onkologisk Klinik	København Ø
Spain	Vall d?Hebron Institute of Oncology (VHIO), Barcelona	Barcelona
Spain	Centro Integral Oncologico Clara Campal; Servicio de Oncología	Madrid
Spain	Fundacion Jimenez Diaz; Servicio de Oncologia	Madrid
Spain	Clinica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia	Valencia
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)		Up to 31 months
Primary	Percentage of Participants with Dose-Limiting Toxicities (DLTs)		Up to 31 months
Primary	Objective Response Rate (ORR) (Part II and III only)		Up to 31 months
Secondary	Objective Response Rate (ORR) (Part I only)		Up to 31 months
Secondary	Disease Control Rate (DCR)		Up to 31 months
Secondary	Duration of Response (DoR)		Up to 31 months
Secondary	Progression-Free Survival (PFS)		Up to 31 months
Secondary	Overall Survival (OS)		Up to 31 months
Secondary	Area under the Curve (AUC) of RO7296682		Up to 31 months
Secondary	Minimum Concentration (Cmin) of RO7296682		Up to 31 months
Secondary	Maximum Concentration (Cmax) of RO7296682		Up to 31 months
Secondary	Time of maximum concentration (Tmax) of RO7296682		Up to 31 months
Secondary	Volume of distribution at steady-state conditions (Vss) of RO7296682		Up to 31 months
Secondary	Half-life (t~1/2) of RO7296682		Up to 31 months
Secondary	Treatment-induced changes in Treg levels in blood and/or tumor as compared to baseline		Up to 31 months
Secondary	Treatment-induced changes in Teff/Treg (T-effector cell; T-regulatory cell) ratio in blood and/or tumor as compared to baseline		Up to 31 months