Study of RO7515629 in Participants With HLA-G Positive Solid Tumors

NCT05769959 | Terminated Phase 1 FDA Drug

• 1 other identifier: BP44068
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, immune response and preliminary anti-tumor activity of RO7515629 alone in participants with advanced or metastatic solid tumors expressing human leukocyte antigen G (HLA-G).

Conditions

Renal Cell Carcinoma; Non-small Cell Lung Cancer; Pancreatic Adenocarcinoma; Colorectal Cancer; Ovarian Neoplasms

Keywords

HLA-G; Human leukocyte antigen G; Renal cell carcinoma; Non-small cell lung cancer; Pancreatic adenocarcinoma; Colorectal cancer; Epithelial ovarian cancer; Primary peritoneal cancer; Fallopian tube cancer; RO7515629; Tocilizumab

Outcome Measures

Primary Outcomes (2)

• Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to 15 months

• Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)

  From start of study treatment (cycle 0 day -7 or cycle 0 day -14) until two weeks after second or third RO7515629 infusion (cycle 1 day 1) for a total DLT window of up to 28 days.

Secondary Outcomes (12)

• Part 1, 2, 3: Pharmacokinetic Analysis: Maximum Serum Concentration (Cmax) of RO7515629

  Up to 13 months

• Part 1, 2, 3: Pharmacokinetic Analysis: Time of Maximum Serum Concentration (Tmax) of RO7515629

  Up to 13 months

• Part 1, 2, 3: Pharmacokinetic Analysis: Minimum Serum Concentration (Cmin) of RO7515629

  Up to 13 months

• Parts 1, 2, 3: Pharmacokinetic Analysis: Clearance (CL) of RO7515629

  Up to 13 months

• Part 1, 2, 3: Pharmacokinetic Analysis: Volume of Distribution at Steady State (Vss) of RO7515629

  Up to 13 months

Study Arms (3)

Part I Single Participant Cohort RO7515629 Dose Escalation

EXPERIMENTAL

Participants will receive a fixed dose of RO7515629 intravenously as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Drug: RO7515629; Drug: tocilizumab

Part II Multiple Participant Cohort RO7515629 Dose Escalation

EXPERIMENTAL

Participants will receive RO7515629 intravenously, as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. In case of toxicity, step up dosing (single or double) may be implemented. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Drug: RO7515629; Drug: tocilizumab

Part III Multiple Participant Cohort RO7515629 Dose Expansion

EXPERIMENTAL

Participants with selected solid tumors will receive a selected dose of RO7515629 intravenously as a single agent based on the recommended dose sequence for expansion (RDE) and dosing regimen selected from Part I and Part II. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Drug: RO7515629; Drug: tocilizumab

Interventions

RO7515629 DRUG

RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

Part I Single Participant Cohort RO7515629 Dose Escalation; Part II Multiple Participant Cohort RO7515629 Dose Escalation; Part III Multiple Participant Cohort RO7515629 Dose Expansion

tocilizumab DRUG

Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Also known as: Actemra, RoActemra

Part I Single Participant Cohort RO7515629 Dose Escalation; Part II Multiple Participant Cohort RO7515629 Dose Escalation; Part III Multiple Participant Cohort RO7515629 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable and/or metastatic HLA-G-positive solid tumors, for which standard therapy does not exist, or has proven to be ineffective or intolerable
• Confirmed HLA-G tumor expression.
• Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematological, liver, renal and pulmonary function
• Willingness to abide by protocol defined contraceptive requirements for the duration of the study.

You may not qualify if:

• History or clinical evidence of Central Nervous System (CNS) metastases unless protocol specified criteria are met
• Leptomeningeal metastases
• Rapid disease progression including lesions that are a threat to vital organs or non-irradiated lesions 2cm or larger at critical sites where tumor swelling may pose a risk to critical anatomical structures
• Participants with another invasive malignancy in the last 2 years unless protocol specified criteria are met
• Uncontrolled hypertension
• Active interstitial lung disease (ILD), pneumonitis or a history of ILD/pneumonitis requiring treatment with steroids, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan
• Participants with central cavitation or tumor(s) shown to be invading or abutting major blood vessels by imaging or the Investigator determines the tumor(s) is likely to invade major blood vessels and cause fatal bleeding
• Participants with pulmonary military metastatic pattern or pulmonary lymphangitic carcinomatosis
• History of pulmonary embolism within 3 months prior to study entry
• Significant cardiovascular disease
• Presence of active or uncontrolled infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to initiation of study treatment.
• Known hepatitis B or C (actively replicating) based on protocol specified criteria
• Known Human Immunodeficiency Virus (HIV) positivity
• Presence of an indwelling line or drain
• Active auto-immune disease that has required systemic therapy within the past 2 years unless protocol specified exceptions are met

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: June 15, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)