NSCLCPhase 1/2NCT05383898
Study to Evaluate D-1553 in Subjects With Lung Cancer
A Phase 1/2 study testing D-1553 in people with NSCLC, run by InventisBio Co., Ltd at 2 sites in China.
Trial summary
This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- D-1553
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesChina
- Study dates
- 16 Mar 2021to 17 May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 NSCLC 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 containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
- Subject has measurable disease according to RECIST, v1.1
Who cannot join
- Subject with unstable or progressive central nervous system (CNS) metastases.
- Subjects with clinically significant cardiovascular disease
- Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
- Subject is pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, 310005
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors
This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation
- Conditions
- NSCLC
- Being tested
- D-1553
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 novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose escalation of D-1553 | Experimental | Phase 1a will evaluate up to sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation Receives: Drug: D-1553 |
| Phase 1b Dose expansion of D-1553 | Experimental | Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose. Receives: Drug: D-1553 |
| Phase 2 of D-1553 monotherapy | Experimental | Phase 1b will evaluate more subjects at the recommended phase 2 dose of D-1553 to evaluate the efficacy. Receives: Drug: D-1553 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of Dose-limiting toxicities (DLT)
Subject incidence of Dose-limiting toxicities (DLT)
Measured: through out the DLT period, approximately 21 days
Number of subjects participants with adverse events
Number of subjects participants with adverse events
Measured: Through study completion, approximately 3 years
antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation
Overall Response Rate (ORR, Complete Response [CR] + Partial Response [PR])
Measured: Through study completion, approximately 3 years
Secondary outcomes (1)
Plasma concentration of D-1553
Plasma concentration of D-1553 as a single agent in subjects with advanced or metastatic NSCLC with KRas G12C mutation
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start16 Mar 2021
- Primary completion17 Nov 2023
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383898
- Sponsor's protocol ID
- D1553-102
- Status last verified
- Oct 2024
- First submitted
- 13 May 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song Z, Li Z, Zhang Y, Wang P, Jiang L, Zhao Y, Zhou J, Wang X, Zhuang W, Shi J, Huang D, Dang X, Cang S, Gong Y, Jin S, Li W, Dong X, Zhang J, Zhao M, Meng X, Liu X, Fang J, Wu P, Lu J, Zhang L, Yang J, Wang X, Luo H, Cui J, Zhang Z, Wang J, Li G, Wu L, Yu Y, Fang Y, Lv D, Yang W, Chen L, Yang N, Li K, Ma R, Wang M, Zhou H, Hu S, Li Q, Zhuang Z, Cao B, Zhu W, Xu C, Wang W, Xiang Z, Shi Z, Wang Y, Zhang L, Lu S. Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study. Eur J Cancer. 2026 Jan;232:116153. doi: 10.1016/j.ejca.2025.116153. Epub 2025 Nov 29.
PubMed 41330054Li Z, Dang X, Huang D, Jin S, Li W, Shi J, Wang X, Zhang Y, Song Z, Zhang J, Zhuang W, Liu X, Jiang L, Meng X, Zhao M, Zhou J, Zhang L, Wang P, Luo H, Yang J, Cang S, Wang X, Zhang L, Lu S; D1553-102 Study Group. Garsorasib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial. Lancet Respir Med. 2024 Aug;12(8):589-598. doi: 10.1016/S2213-2600(24)00110-3. Epub 2024 Jun 10.
PubMed 38870979Li Z, Song Z, Zhao Y, Wang P, Jiang L, Gong Y, Zhou J, Jian H, Dong X, Zhuang W, Cang S, Yang N, Fang J, Shi J, Lu J, Ma R, Wu P, Zhang Y, Song M, Xu CW, Shi Z, Zhang L, Wang Y, Wang X, Zhang Y, Lu S. D-1553 (Garsorasib), a Potent and Selective Inhibitor of KRASG12C in Patients With NSCLC: Phase 1 Study Results. J Thorac Oncol. 2023 Jul;18(7):940-951. doi: 10.1016/j.jtho.2023.03.015. Epub 2023 Mar 21.
PubMed 36948246
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. 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 Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05383898
- Acronym / sponsor ID
- D1553-102
- Conditions
- NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 20 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 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose escalation of D-1553 | Experimental | Drug: D-1553Phase 1a will evaluate up to sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation |
| Phase 1b Dose expansion of D-1553 | Experimental | Drug: D-1553Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose. |
| Phase 2 of D-1553 monotherapy | Experimental | Drug: D-1553Phase 1b will evaluate more subjects at the recommended phase 2 dose of D-1553 to evaluate the efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject with histologically proven, locally advanced, unresectable and/or metastatic NSCLC 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 containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
- Subject has measurable disease according to RECIST, v1.1
Key exclusion criteria (5 listed)
- Subject with unstable or progressive central nervous system (CNS) metastases.
- Subjects with clinically significant cardiovascular disease
- Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
- Subject is pregnant or lactating.
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 novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation. | Drug | Phase 1a Dose escalation of D-1553, Phase 1b Dose expansion of D-1553, Phase 2 of D-1553 monotherapy |
Primary outcome
Subject incidence of Dose-limiting toxicities (DLT)
Time frame: through out the DLT period, approximately 21 days
Subject incidence of Dose-limiting toxicities (DLT)
Number of subjects participants with adverse events
Time frame: Through study completion, approximately 3 years
Number of subjects participants with adverse events
antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation
Time frame: Through study completion, approximately 3 years
Overall Response Rate (ORR, Complete Response [CR] + Partial Response [PR])
1 secondary outcome
Plasma concentration of D-1553
Time frame: approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41330054Song Z, Li Z, Zhang Y, Wang P, Jiang L, Zhao Y, Zhou J, Wang X, Zhuang W, Shi J, Huang D, Dang X, Cang S, Gong Y, Jin S, Li W, Dong X, Zhang J, Zhao M, Meng X, Liu X, Fang J, Wu P, Lu J, Zhang L, Yang J, Wang X, Luo H, Cui J, Zhang Z, Wang J, Li G, Wu L, Yu Y, Fang Y, Lv D, Yang W, Chen L, Yang N, Li K, Ma R, Wang M, Zhou H, Hu S, Li Q, Zhuang Z, Cao B, Zhu W, Xu C, Wang W, Xiang Z, Shi Z, Wang Y, Zhang L, Lu S. Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study. Eur J Cancer. 2026 Jan;232:116153. doi: 10.1016/j.ejca.2025.116153. Epub 2025 Nov 29.
- Derived from this study: PubMed 38870979Li Z, Dang X, Huang D, Jin S, Li W, Shi J, Wang X, Zhang Y, Song Z, Zhang J, Zhuang W, Liu X, Jiang L, Meng X, Zhao M, Zhou J, Zhang L, Wang P, Luo H, Yang J, Cang S, Wang X, Zhang L, Lu S; D1553-102 Study Group. Garsorasib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial. Lancet Respir Med. 2024 Aug;12(8):589-598. doi: 10.1016/S2213-2600(24)00110-3. Epub 2024 Jun 10.
- Derived from this study: PubMed 36948246Li Z, Song Z, Zhao Y, Wang P, Jiang L, Gong Y, Zhou J, Jian H, Dong X, Zhuang W, Cang S, Yang N, Fang J, Shi J, Lu J, Ma R, Wu P, Zhang Y, Song M, Xu CW, Shi Z, Zhang L, Wang Y, Wang X, Zhang Y, Lu S. D-1553 (Garsorasib), a Potent and Selective Inhibitor of KRASG12C in Patients With NSCLC: Phase 1 Study Results. J Thorac Oncol. 2023 Jul;18(7):940-951. doi: 10.1016/j.jtho.2023.03.015. Epub 2023 Mar 21.
- 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. This study is not recruiting at the moment.
Shun Lu, MD principal investigator
Shanghai Chest Hospital
2 sites 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 in people with NSCLC, run by InventisBio Co., Ltd at 2 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject incidence of Dose-limiting toxicities (DLT) (time frame: through out the DLT period, approximately 21 days). The study lists 3 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 NCT05383898, which also lists 3 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 15 Oct 2024.