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

Colorectal Cancer Clinical Trial

Official title:

An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7515629 in Participants With Unresectable and/or Metastatic HLA-G Positive Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05769959
• Other study ID #: BP44068
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: June 15, 2023
• Est. completion date: March 19, 2024

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 19, 2024
• Est. primary completion date: March 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Major surgery within 28 days prior to first study treatment

• Last treatment with anti-cancer therapy or any investigational drug 28 days or less prior to the first study treatment

• Last dose of immunostimulating or immunosuppressive therapy 28 days or less prior to the first study treatment

• Regular dose of corticosteroids that exceeds prednisone 10 mg/day or equivalent within 28 days prior to first study treatment

• Prior treatment with T cell engaging or adoptive cell therapy

• Administration of a live, attenuated vaccine 28 days or less prior to first study treatment

• Contraindication or known hypersensitivity to any of the components of RO7515629 or tocilizumab or dexamethasone

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Non-small Cell Lung Cancer
• Ovarian Neoplasms
• Pancreatic Adenocarcinoma
• Renal Cell Carcinoma

Intervention

Drug:
• RO7515629
RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
• tocilizumab
Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute at HealthONE	Denver	Colorado
United States	SCRI Oncology Partners	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to 15 months
Primary	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	Part 1, 2, 3: Pharmacokinetic Analysis: Maximum Serum Concentration (Cmax) of RO7515629		Up to 13 months
Secondary	Part 1, 2, 3: Pharmacokinetic Analysis: Time of Maximum Serum Concentration (Tmax) of RO7515629		Up to 13 months
Secondary	Part 1, 2, 3: Pharmacokinetic Analysis: Minimum Serum Concentration (Cmin) of RO7515629		Up to 13 months
Secondary	Parts 1, 2, 3: Pharmacokinetic Analysis: Clearance (CL) of RO7515629		Up to 13 months
Secondary	Part 1, 2, 3: Pharmacokinetic Analysis: Volume of Distribution at Steady State (Vss) of RO7515629		Up to 13 months
Secondary	Part 1, 2, 3: Pharmacokinetic Analysis: Area Under The Curve (AUC) of RO7515629		Up to 13 months
Secondary	Part 1, 2, 3: Number of Participants With RO7515629 Anti-drug Antibodies (ADAs)		Up to 13 months
Secondary	Part 1, 2, 3: Objective Response Rate (ORR)		Up to approximately 18 months
Secondary	Part 1, 2, 3: Disease Control Rate (DCR)		Up to approximately 18 months
Secondary	Part 1, 2, 3: Duration of Response (DoR)		Up to approximately 18 months
Secondary	Part 1, 2, 3: Progression Free Survival (PFS)		Up to approximately 18 months
Secondary	Part 1, 2, 3: Overall survival (OS)	Defined as the time from first dose of study treatment to time of death.	Up to approximately 18 months