Advanced KRAS G12D Mutant Solid TumorsPhase 1NCT07134998
Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
A Phase 1 study testing HRS-6093 in people with Advanced KRAS G12D Mutant Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced KRAS G12D Mutant Solid Tumors
- What is being tested?
- HRS-6093
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesChina
- Study dates
- 16 Sep 2025to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, are intolerant to standard treatment, or have not received 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
Who cannot join
- 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;
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- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Dan Cao
- Recruiting
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Baiyong Shen
About this study
Official title: A Phase I Study of HRS-6093 Evaluating Safety, Tolerability, and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
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.
- Conditions
- Advanced KRAS G12D Mutant Solid Tumors
- Being tested
- HRS-6093
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6093Drug
HRS-6093
| Study group | Role | What they receive |
|---|---|---|
| HRS-6093 | Experimental | Not described Receives: Drug: HRS-6093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events/serious adverse events (graded as per CTCAE v5.0).
Measured: Screening Period to 30 Days After the Last Dose
DLT,
Measured: from day1 to day 23; 23 Days
MTD,
Measured: from day1 to day 23; 23 Days
RP2D ,
Measured: 24 months
Secondary outcomes (15)
Number of Participants With Abnormal Laboratory Values
Measured: Screening Period to 30 Days After the Last Dose; 24 months
Number of subjects with clinically significant changes in ECOG, vital signs and physical examination.
Measured: Screening Period to 30 Days After the Last Dose; 24 months
Number of subjects with changes on ECG.
Measured: Screening Period to 30 Days After the Last Dose; 24 months
maximum plasma concentration (Cmax),
Measured: Screening Period to Day of the end of treatment/withdrawal. 24 months
time to maximum concentration (Tmax),
Measured: Screening Period to Day of the end of treatment/withdrawal. 24 months
area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t),
Measured: Screening Period to Day of the end of treatment/withdrawal. 24 months
Area under concentration-time curve from time 0 to infinity (AUC 0-∞), apparent volume of distribution (Vz/F),
Measured: Screening Period to Day of the end of treatment/withdrawal. 24 months
elimination half-life (t1/2), and apparent clearance (CL/F);
Measured: Screening Period to Day of the end of treatment/withdrawal. 24 months
minimum concentration at steady state (Cmin, ss),
Measured: Screening Period to Day of the end of treatment/withdrawal. 24 months
area under the blood concentration-time curve at steady state (AUCss), and accumulation ratio (Rac);
Measured: Screening Period to Day of the end of treatment/withdrawal. 24 months
objective response rate (ORR),
Measured: Screening Period to PD; 24 months
duration of response (DoR),
Measured: Screening Period to PD; 24 months
disease control rate (DCR),
Measured: Screening Period to PD; 24 months
progression-free survival (PFS),
Measured: Screening Period to PD; 24 months
overall survival (OS).
Measured: Screening Period to Day of death of the participant;24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start16 Sep 2025
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced KRAS G12D Mutant Solid TumorsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134998
- Sponsor's protocol ID
- HRS-6093-101
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided