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A Phase 1/2, Open-label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation

UCI Specialty Areas: Cancer, Orthopaedics
Principal Investigator: Misako Nagasaka
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

This first-in-human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of D3S-001 and identify the recommended Phase 2 dose (RP2D) when D3S-001 is administered as monotherapy to subjects with advanced solid tumors with the Kirsten rat sarcoma viral oncogene homolog gene (KRAS) p.G12C mutation.

Eligibility

You can participate in this study if

  • Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
  • Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
  • Subject must have measurable disease per RECIST v1.1.
  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject must have adequate organ and marrow function within the screening period.

You cannot participate in this study if

  • Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
  • Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring (Adverse Events) AEs, or compromise the ability of the subject to give written informed consent.
  • Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade >2 (with exception of vitiligo or alopecia).
  • Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
  • Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
    time. If you decide to withdraw from this database you should notify the research team
    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
  • Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.
  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
  • There is no compensation for your participation in this database.
  • There is no cost to you for participation in this database.
  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
  • Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.
  • The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.
  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
  • If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form
  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI