A Study of LY3435151 in Participants With Solid Tumors

Lilly

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor; Leiomyosarcoma; Triple-negative Breast Cancer; Undifferentiated Pleomorphic Sarcoma; Hepatocellular Carcinoma; Cervical Carcinoma; High Grade Serous Ovarian Carcinoma; Head and Neck Squamous Cell Carcinoma; Gastric Adenocarcinoma

Treatments: Drug: LY3435151; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04099277

J1Q-MC-JZIA (Other Identifier)

17364

Details and patient eligibility

About

The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have certain types of cancer, which your study doctor will discuss with you
• Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you
• Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b)
• Participant must agree to use birth control
• Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you

Exclusion criteria

• Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection
• Participant must not have an autoimmune disease, which your study doctor will discuss with you
• Participant must not use corticosteroids, which your study doctor will discuss with you
• Participant must not have heart disease, Crohn's disease or brain cancer
• Participant must not be pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

Part A: 10 milligrams (mg) LY3435151

Experimental group

Description:

Participants received intravenous (IV) push or IV bolus infusion of 10 mg LY3435151.

Treatment:

Drug: LY3435151

Part B: LY3435151 + Pembrolizumab Dose Escalation

Experimental group

Description:

Pembrolizumab was not administered as study was terminated before completion of Part A of the dose escalation period.

Treatment:

Drug: LY3435151

Drug: Pembrolizumab

Part C: LY3435151 Dose Expansion

Experimental group

Description:

Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase.

Treatment:

Drug: LY3435151

Part D: LY3435151 + Pembrolizumab Dose Expansion

Experimental group

Description:

Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase.

Treatment:

Drug: LY3435151

Drug: Pembrolizumab