MOONRAY-01, A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors

ENROLLING
Protocol # :
24-621
Conditions
Pancreatic Ductal Adenocarcinoma
Non-Small Cell Lung Cancer
Colorectal Cancer
Phase
I
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Other specified personal risk factors, not elsewhere classified
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Huffman, Brandon
Site Research Nurses
Belavusava, Vera
Bretta, Katherine
Connelly, Alexandra
Engelbrecht, Liliana
Giannandrea, Gianna
Graham, Christopher
Hindenach, Sarah, E.
Libertini, Kelsie, Elizabeth
McNamara, Taylor
Morrissey, Stephanie, C.
Neals, Allison
Platia, Delaney
Ritterband, Lauren
Sawin, Mark
Vanasse, Katherine

Trial Description

The main purpose of this study is to assess safety & tolerability and antitumor activity
of LY3962673 as monotherapy and in combination with other chemotherapy agents in
participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to
last approximately 5 years.

Eligibility Requirements

Inclusion Criteria:

- Have Histological or cytologically proven diagnosis of locally advanced,
unresectable, and/or metastatic cancer and measurable disease per Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

- Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA

- Have an ECOG performance status of ≤ 1

- Must have received ≥ 1 prior line of systemic chemotherapy for advanced or
metastatic disease

- Participants with asymptomatic or treated CNS disease may be eligible.

Exclusion Criteria:

- Have known active CNS metastases and/or carcinomatous meningitis.

- Have any unresolved toxicities from prior therapy greater than National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.

- Have significant cardiovascular disease as unstable angina or acute coronary
syndrome, history of myocardial infarction, known reduced left ventricular ejection
fraction.

- Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.

- Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).

- Have other active malignancy unless in remission with life expectancy greater than
(>) 2 years.

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