Study to Evaluate D-1553 in Subjects With Solid Tumors
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 With KRasG12C Mutation
2 other identifiers
interventional
180
4 countries
25
Brief Summary
This is a phase 1/2, open label study of D-1553 single agent and combination 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 solid tumor with KRasG12C mutation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2020
Longer than P75 for phase_1
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2020
CompletedStudy Start
First participant enrolled
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 18, 2025
October 1, 2024
3.6 years
September 27, 2020
March 13, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Subject incidence of Dose-limiting toxicities (DLT)
through out the DLT period, approximately 21 days
Number of subjects participants with adverse events
Through study completion, approximately 3 years
Plasma concentration of D-1553 as a single agent or in combination with other therapies in subjects wiht advanced or metastatic solid tumors with KRas G12C mutation.
Through study completion, approximately 3 years
Study Arms (3)
Dose escalation of D-1553 monotherapy
EXPERIMENTALPhase 1a will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation.
Dose combination of D-1553 with other therapies
EXPERIMENTALPhase 1b will determine the MTD of D-1553 in combination treatment in subjects with advanced or metastatic NSCLC, CRC and other solid tumors. There are multiple groups in Phase 1b for different tumor types and treatment combinations to evaluate safety, MTD and RP2D.
Phase 2 of D-1553 monotherapy and combination therapies
EXPERIMENTALThe Phase 2 portion is a multi-arm, parallel, open label study to evaluate the efficacy of D- 1553 single agent and combination treatments in subjects with advanced or metastatic solid tumors with KRas G12C mutation. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose.
Interventions
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.
Standard treatment of solid tumor, NSCLC or CRC
Eligibility Criteria
You may qualify if:
- 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 bio-specimens 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 tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
- Subject has measurable disease according to RECIST, v1.1.
You may not qualify if:
- 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 has any history or evidence of substance abuse or medical, psychological or social conditions that may, in the opinion of the investigator, interfere with participation in the study or evaluation of the study results.
- Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
- Subject has unresolved toxicities from prior anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE, v5.0, Grade ≤ 1 (Grade ≤ 2 for peripheral neuropathy).
- Subject had major surgery within 4 weeks prior to study intervention administration or last dose of palliative radiation therapy within 2 weeks prior to study intervention administration.
- Subject is pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InventisBio Co., Ltdlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (25)
Research Site
Fresno, California, 93720, United States
Research Site
Orange, California, 92868, United States
Research Site
San Francisco, California, 94158, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
New York, New York, 11432, United States
Research Site
Portland, Oregon, 97213, United States
Research Site
Blacktown, New South Wales, 2148, Australia
Research Site
East Albury, New South Wales, 2640, Australia
Research Site
Kogarah, New South Wales, 2217, Australia
Research Site
Waratah, New South Wales, 2298, Australia
Research Site
Woodville South, South Australia, 5011, Australia
Research Site
Fitzroy, Victoria, 3065, Australia
Research Site
Frankston, Victoria, 3199, Australia
Research Site
Malvern, Victoria, 3144, Australia
Research Site
Nedlands, Western Australia, 6009, Australia
Research Site
Seogu, Busan, 602-715, South Korea
Research Site
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 138-736, South Korea
Research Site
Seoul, 152-703, South Korea
Research Site
Tainan, 704, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taoyuan, 333, Taiwan
Related Publications (1)
Ruan DY, Wu HX, Xu Y, Munster PN, Deng Y, Richardson G, Yan D, Lee MA, Lee KW, Pan H, Hager S, Li X, Wei S, Hou X, Underhill C, Millward M, Nordman I, Zhang J, Shan J, Han G, Grewal J, Gadgeel SM, Sanborn RE, Huh SJ, Hu X, Zhang Y, Xiang Z, Luo L, Xie X, Shi Z, Wang Y, Zhang L, Wang F, Xu RH. Garsorasib, a KRAS G12C inhibitor, with or without cetuximab, an EGFR antibody, in colorectal cancer cohorts of a phase II trial in advanced solid tumors with KRAS G12C mutation. Signal Transduct Target Ther. 2025 Jun 17;10(1):189. doi: 10.1038/s41392-025-02274-z.
PMID: 40523897DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2020
First Posted
October 14, 2020
Study Start
October 2, 2020
Primary Completion
April 30, 2024
Study Completion
December 1, 2025
Last Updated
March 18, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share