Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
D3 Bio (Wuxi) Co., Ltd (Voir sur ClinicalTrials)
août 2022
avril 2027
02 décembre 2025
This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and
dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination
therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken
daily by oral administration in 21-day treatment cycles.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 24/07/2026 14:30:06 | Contacter | ||
Critères
Tous
Inclusion:
- 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.
Exclusion:
- 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 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).
Other protocol inclusion/exclusion criteria may apply
- 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.
Exclusion:
- 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 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).
Other protocol inclusion/exclusion criteria may apply