Solid TumorPhase 1/2NCT05379946
Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors
A Phase 1/2 study testing D-1553 and IN10018 in people with Solid Tumor, run by InventisBio Co., Ltd at 1 site in China.
Trial summary
This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- D-1553 and IN10018
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2022to 31 Aug 2029
- Phase
- Phase 1/2
- 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
- Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
- Subject has KRasG12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used.
- Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
- Subject has measurable disease according to RECIST, v1.1
Who cannot join
- Subject with unstable or progressive central nervous system (CNS) metastases.
- Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
- Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).
- Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
- Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
- Subject is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, 310005
About this study
Official title: A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation
This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation
- Conditions
- Solid Tumor
- Being tested
- D-1553, IN10018
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-1553Drug
D-1553 is a oral dosed novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation
IN10018Drug
IN10018 orally once daily at approximately the same time each day
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Dose escalation of D-1553 plus IN10018 | Experimental | Phase 1b will evaluate up sequential cohorts with different doses of IN10018 together with D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation. Receives: Drug: D-1553; Drug: IN10018 |
| Phase 2 Doseexpansion of D-1553 plus IN10018 | Experimental | Phase 2 will include more subjects to further evaluate the safety and efficacy of D-1553 in combination with IN10018 in patients with solid tumors with KRasG12C mutation. Receives: Drug: D-1553; Drug: IN10018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Number of subjects participants with adverse events
Measured: Through study completion, approximately 3 years
Objective response rate (ORR) per RECIST v1.1
Defined as the proportion of patients with complete response (CR) or partial response (PR).
Measured: Through study completion, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start12 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InxMed (Shanghai) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhengbo Song, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379946
- Sponsor's protocol ID
- D1553-106
- Status last verified
- Jul 2026
- First submitted
- 13 May 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song Z, Zhu L, Liu Y, Lin R, Li X, Luo Y, Yuan Y, Shi H, Zhang Y, Zhang B, Zhu Y, Wang Z, Cheng X. Ifebemtinib plus garsorasib in previously treated metastatic colorectal cancer with KRASG12C mutation: a multicentre, randomised, phase 1b/2 trial. Lancet Oncol. 2026 Sep;27(9):1133-1145. doi: 10.1016/S1470-2045(26)00175-0.
PubMed 42636835Song Z, Li X, Lin R, Shi H, Yuan Y, Liu Y, Luo Y, Lv T, Zhang Y, Zhu L, Zhu Y, Zhang L, Wang Z. Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. Lancet Respir Med. 2026 Jul 7:S2213-2600(26)00142-6. doi: 10.1016/S2213-2600(26)00142-6. Online ahead of print.
PubMed 42413526
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation
- ClinicalTrials.gov ID
- NCT05379946
- Acronym / sponsor ID
- D1553-106
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- InxMed (Shanghai) Co., Ltd.
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 18 May 2022 (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 is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Dose escalation of D-1553 plus IN10018 | Experimental | Drug: D-1553, Drug: IN10018Phase 1b will evaluate up sequential cohorts with different doses of IN10018 together with D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation. |
| Phase 2 Doseexpansion of D-1553 plus IN10018 | Experimental | Drug: D-1553, Drug: IN10018Phase 2 will include more subjects to further evaluate the safety and efficacy of D-1553 in combination with IN10018 in patients with solid tumors with KRasG12C mutation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
- Subject has KRasG12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used.
- Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
- Subject has measurable disease according to RECIST, v1.1
Key exclusion criteria (6 listed)
- Subject with unstable or progressive central nervous system (CNS) metastases.
- Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
- Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).
- Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
- Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
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 |
|---|---|---|
| D-1553D-1553 is a oral dosed novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation | Drug | Phase 1b Dose escalation of D-1553 plus IN10018, Phase 2 Doseexpansion of D-1553 plus IN10018 |
| IN10018IN10018 orally once daily at approximately the same time each day | Drug | Phase 1b Dose escalation of D-1553 plus IN10018, Phase 2 Doseexpansion of D-1553 plus IN10018 |
Primary outcome
adverse events
Time frame: Through study completion, approximately 3 years
Number of subjects participants with adverse events
Objective response rate (ORR) per RECIST v1.1
Time frame: Through study completion, approximately 3 years
Defined as the proportion of patients with complete response (CR) or partial response (PR).
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 17 Jul 2026.
- Derived from this study: PubMed 42636835Song Z, Zhu L, Liu Y, Lin R, Li X, Luo Y, Yuan Y, Shi H, Zhang Y, Zhang B, Zhu Y, Wang Z, Cheng X. Ifebemtinib plus garsorasib in previously treated metastatic colorectal cancer with KRASG12C mutation: a multicentre, randomised, phase 1b/2 trial. Lancet Oncol. 2026 Sep;27(9):1133-1145. doi: 10.1016/S1470-2045(26)00175-0.
- Derived from this study: PubMed 42413526Song Z, Li X, Lin R, Shi H, Yuan Y, Liu Y, Luo Y, Lv T, Zhang Y, Zhu L, Zhu Y, Zhang L, Wang Z. Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. Lancet Respir Med. 2026 Jul 7:S2213-2600(26)00142-6. doi: 10.1016/S2213-2600(26)00142-6. Online ahead of print.
- Individual participant dataSharing planned: No
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Solid Tumors
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. This study is not recruiting at the moment.
Zhengbo Song principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing D-1553 and IN10018 in people with Solid Tumor, run by InventisBio 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 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: Through study completion, approximately 3 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?
On the ClinicalTrials.gov record for NCT05379946, which also lists 2 linked publications.
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 17 Jul 2026.