Non-small Cell Lung Cancer (NSCLC)Phase 1NCT07624214
Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors
A Phase 1 study testing LT-010391 in people with Non-small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), run by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. at 1 site in China.
Trial summary
This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- LT-010391
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;
- Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;
- ECOG Performance Status of 0 or 1;
- Adequate organ function
Who cannot join
- History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;
- Primary central nervous system (CNS) tumors
- leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song, MD, 86571-88122146, irb@zjcc.org.cn
Zhengbo Song, MD
About this study
Official title: A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
Read the detailed description
This is an open-label, multicenter, Phase 1 study of LT-010391, a selective and orally bioavailable KRAS G12D degrader in participants with KRAS G12D mutant advanced solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two parts: Part A- dose escalation and Part B- dose expansion.
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
- Being tested
- LT-010391
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-010391Drug
LT-010391 tablets, oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts | Experimental | Part A: Dose Escalation Participants will receive the designated dose. Enrollment into dose escalation may be from any advanced solid tumors with KRAS G12D mutation.
Part B: Dose Expansion:
Upon completing DLT observation for a dose level, investigators and sponsor may discuss selecting a specific cancer type for expansion at prior dose. Receives: Drug: LT-010391 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
Measured: Up to 2 years
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs)
Measured: 21 days
Secondary outcomes (5)
Pharmacokinetic parameters
Cmax will be recorded from the PK plasma samples collected.
Measured: up to 15 weeks
Overall Response Rate (ORR)
Assess per RECIST v1.1
Measured: up to 2 years
Duration of Response (DOR)
Assess per RECIST v1.1
Measured: up to 2 years
Disease Control Rate（DCR）
Assess per RECIST v1.1
Measured: up to 2 years
Progression-Free Survival (PFS)
Assess per RECIST v1.1
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624214
- Sponsor's protocol ID
- LT010391US001
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT07624214
- Acronym / sponsor ID
- LT010391US001
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
Detailed description
This is an open-label, multicenter, Phase 1 study of LT-010391, a selective and orally bioavailable KRAS G12D degrader in participants with KRAS G12D mutant advanced solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two parts: Part A- dose escalation and Part B- dose expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts | Experimental | Drug: LT-010391Part A: Dose Escalation Participants will receive the designated dose. Enrollment into dose escalation may be from any advanced solid tumors with KRAS G12D mutation. Part B: Dose Expansion: Upon completing DLT observation for a dose level, investigators and sponsor may discuss selecting a specific cancer type for expansion at prior dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;
- Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;
- ECOG Performance Status of 0 or 1;
- Adequate organ function
Key exclusion criteria (3 listed)
- History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;
- Primary central nervous system (CNS) tumors
- leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT-010391LT-010391 tablets, oral, once daily | Drug | A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts |
Primary outcome
Adverse events
Time frame: Up to 2 years
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
Dose Limiting Toxicities
Time frame: 21 days
Number of participants with Dose Limiting Toxicities (DLTs)
5 secondary outcomes
Pharmacokinetic parameters
Time frame: up to 15 weeks
Overall Response Rate (ORR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Disease Control Rate（DCR）
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LT-010391 in people with Non-small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), run by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. (+86-21-50561622, jxu@leadingtac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.