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A Study of AK-01 (LY3295668) in Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of AK-01 (LY3295668) in Solid Tumors

A Phase I/II Open-Label Multicenter Study to Evaluate the Safety and Efficacy of AK-01 as Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

NCT03092934•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have received at least 1 but no more than 4 prior systemic therapies
•Have adequate organ function
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
•Have estimated life expectancy greater than or equal to (≥)12 weeks
•Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies
•Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior
•Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months
•Male participants must use a barrier method of contraception during the study and for the following 3 months
•Phase 1
•Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)
+8 more criteria

Exclusion Criteria

•Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS
•Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)

Locations (3)

Cross Cancer Institute

Edmonton, Alberta, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Key Dates

Start Date

May 29, 2017

Primary Completion Date

April 20, 2020

Completion Date

April 20, 2020

Last Updated

July 2, 2021

Enrollment

ACTUAL participants

Conditions

NeoplasmsNeoplasm MetastasisTriple Negative Breast NeoplasmsHead and Neck NeoplasmsBreast NeoplasmsSolid Tumor, AdultSmall Cell Lung Carcinoma

Interventions

LY3295668

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGPHASE3

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AK-01 (LY3295668) in Solid Tumors

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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