An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Genentech

Status and phase: Active, not recruiting; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Atezolizumab; Drug: XmAb24306

Study type: Interventional

Funder types: Industry

Identifiers

NCT04250155

GO41596

Details and patient eligibility

About

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key General Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy >/= 12 weeks
• Adequate hematologic and end-organ function
• For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative serum pregnancy test for women of childbearing potential
• Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Availability of representative tumor specimens

Key General Exclusion Criteria

• Pregnant or breastfeeding, or intending to become pregnant during the study
• Significant cardiovascular disease
• Current treatment with medications that prolong the QT interval
• Known clinically significant liver disease
• Poorly controlled Type 2 diabetes mellitus
• Symptomatic, untreated, or actively progressing CNS metastases
• History of leptomeningeal disease
• History of malignancy other than disease under study within 3 years prior to screening
• Active or history of autoimmune disease or immune deficiency
• Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus infection
• Positive for HIV infection
• Prior allogeneic stem cell or solid organ transplantation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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195 participants in 4 patient groups

Phase 1a Dose Escalation

Experimental group

Description:

Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Treatment:

Drug: XmAb24306

Drug: XmAb24306

Phase 1a Dose Expansion

Experimental group

Description:

Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Treatment:

Drug: XmAb24306

Drug: XmAb24306

Phase 1b Dose Escalation

Experimental group

Description:

Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Treatment:

Drug: XmAb24306

Drug: XmAb24306

Drug: Atezolizumab

Phase 1b Dose Expansion

Experimental group

Description:

Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Treatment:

Drug: XmAb24306

Drug: XmAb24306

Drug: Atezolizumab