A study to test if different doses of D3S-001 used on its own are safe and tolerable in people with advanced solid tumors with KRAS p.G12C modificatio
- Conditions
- Advanced Solid Tumors with a KRAS p.G12C MutationMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508517-16-00
- Lead Sponsor
- D3 Bio (Wuxi) Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 165
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. Local KRAS p.G12C testing must be performed using a verified and well-validated test in line with local regulations, performed at a Clinical Laboratory Improvement Amendments certified or a College of American Pathologists accredited laboratory for the United States sites. An equivalent accredited laboratory is required for sites outside the US., Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as defined by at least 1 lesion that can be accurately measured at baseline as =10 mm at the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) (except lymph nodes which must have a short axis =15 mm on CT), which is suitable for accurate, repeated measurements. Previously irradiated lesions or a lesion in the field of radiation should not be used as measurable disease unless the lesion(s) has/have demonstrated unequivocal disease progression by RECIST v1.1. Target lesions should not be used for the baseline tumor biopsy, unless there are no other lesions suitable for biopsy and they fulfil requirements outlined in the study protocol., Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Subjects must have adequate organ and marrow function within the screening period as defined in the study protocol.
Subject has any prior treatment with other treatments without adequate washout periods as defined in the study 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 AEs, or compromise the ability of the subject to give written informed consent., Subject has unresolved treatment-related toxicities from previous anti-cancer therapy of NCI CTCAE Grade =2 (with exception of vitiligo or alopecia). a. The following criteria will be only applied to KRAS p.G12Ci-pretreated subjects. The subjects will be ineligible if any 1 of the following criterion was met in the prior KRAS p.G12Ci treatment period: i. Grade 3 or higher ALT and/or AST increased at >2 occurrences ii. Grade 3 or higher cardiac toxicity (ECG QT corrected interval prolonged and ejection fraction decreased) Note: Subjects with other chronic Grade 2 toxicities (e.g., Grade 2 chemotherapy-induced neuropathy) may be eligible per discretion of the Investigator after consultation with the Medical Monitor. Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment may be included only after consultation with the medical Monitor., Subject has active gastrointestinal disease or other condition (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade =2, malabsorption syndrome, or previous significant bowel resection) that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g., that would preclude adequate absorption of D3S-001.), Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the non-treatment phases of these studies (e.g., follow-up phase).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method