PhI/IB of RMC-6291 Monotherapy in Subj w/ Advanced KRASG12C Mutant Solid Tumors
UCI Specialty Area: Cancer
Principal Investigator:
Sai-Hong Ou
Official Title:
Phase I/IB, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects with Advanced KRASG12C Mutant Solid Tumors
A Study On:
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Ill-Defined Sites
Kaposis sarcoma
Kidney
Larynx
Lip Oral Cavity and Pharynx
Liver
Lung
Melanoma skin
Mycosis Fungoides
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder
Study Description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
Eligibility
You can participate in this study if you :
- must be > or = 18 years of age.
- must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
- ECOG performance status 0 or 1
- Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
- Adequate organ function
You cannot participate in this study if you:
- Have primary central nervous system (CNS) tumors
- Have active brain metastases
- Have known impairment of GI function that would alter the absorption
- Have major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
- Have prior therapy with KRASG12C (ON) inhibitor
Other inclusion/exclusion criteria may apply.
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.