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New treatment option for Advanced KRAS G12D Mutant Solid Tumors
Official title Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
ClinicalTrials.gov ID: NCT07134998
What this study is testing
What is HRS-6093?
HRS-6093 is an investigational medicine, being studied as a potential treatment for advanced kras g12d mutant solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
- Aged between 18-75 years, with no gender requirement;
- Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central...
- ECOG performance status (PS) score of 0 or 1;
- Life expectancy \> 3 months;
You likely can't join if
- Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in...
- Presence of central nervous system (CNS) metastases;
- Participants with gastrointestinal diseases that affect drug administration/absorption
- Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major...
- Presence of serious pulmonary diseases
- Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
See the full eligibility criteria
- Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
- Aged between 18-75 years, with no gender requirement;
- Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment...
- ECOG performance status (PS) score of 0 or 1;
- Life expectancy \> 3 months;
- At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided.
- Adequate organ function
- Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/exclusion criteria;
- Presence of central nervous system (CNS) metastases;
- Participants with gastrointestinal diseases that affect drug administration/absorption
- Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period;
- Presence of serious pulmonary diseases
- Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
- Active or persistent gastrointestinal bleeding within 6 months prior to screening;
- History of allogeneic bone marrow or solid organ transplantation;
- History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
- Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);
- Known history of hypersensitivity to any component of the drug product to be used in the study;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.