A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants with Advanced or Metastatic Solid Tumors with KRAS G12D Mutation.

ENROLLING
Protocol # :
24-255
Conditions
Solid Tumors
Phase
I
Disease Sites
Disease not specified
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
Park, Haeseong
Site Research Nurses
Bennett, Allison
Biddle, Elizabeth
Blake, Alyssa
Capulong, Florylene
Combs, Sarah
Grimes, Hayley
Hevert, Daniel
Mackoul, Anna
Murphy, Mary
Speth, Celia
Treveloni, Emily
Vanasse, Richard

Trial Description

This study is conducted to determine the safety and tolerability of INCB161734 as a
single agent or in combination with other anticancer therapies.

Eligibility Requirements

Inclusion Criteria:

- ≥18 years old.

- Locally advanced or metastatic solid tumor with KRAS G12D mutation.

- For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior
standard treatment, intolerance to or ineligibility for standard treatment, declined
available therapies that are known to confer clinical benefit, or no standard
available treatment to improve the disease outcome.

- Cohort specific requirements aas defined in the protocol.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- Prior treatment with any KRAS G12D inhibitor

- Known additional invasive malignancy within 1 year of the first dose of study drug

- History of organ transplant, including allogeneic stem cell transplantation

- Significant, uncontrolled medical condition

- History or presence of an ECG abnormality

- Inadequate organ function

Other protocol-defined Inclusion/Exclusion Criteria may apply

24-255